FDA 3632 Laser (esubmitter)

Submission Report

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Submission Report
eRadHealth Menu
Introduction

Electronic Product Radiation Safety Reporting
Form
This software application is intended to automate the hard copy product reporting forms in the effort
of the Center for Devices and Radiological Health (CDRH) to become capable of accepting
electronic submissions from industry and to improve our review process. This FDA Electronic
Submission (eSub) software is the next version of the application developed to allow us to accept all
Radiological Health reports and other submissions electronically and improve the ability of CDRH
to accomplish its mandated product and industry evaluations in a timely and efficient manner.
All electronic reports and correspondence can either be transferred to CD and mailed to the address
below, or can be sent via the FDA Electronic Submissions Gateway to CDRH. If you follow
instructions to set up an account with the FDA Gateway, it currently may take several weeks,, but
when you submit through it you will receive your acknowledgement email message with Accession
Number within minutes! Or, in the interest of faster turn-around for a one-time urgent report of if
you submit few reports, you may simply fill out this template creating the submission and then at
'Packaging' follow the instructions to transfer the files to a CD to mail in. This method of submitting
your report will be acknowledged by an email with the Accession Number within several days.
Information about the FDA Electronic Submissions Gateway can be found at
www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/default.htm. Please contact the
Gateway Helpdesk with your questions about that system.
Electronic submissions on CD should be mailed directly to the Document Control Center at:
U.S. Food and Drug Administration
Center for Devices and Radiological Health
Attn: eSubmitter Team
Document Mail Center - WO66-0609
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
Submissions received in the mail on CD will be processed within a few days of receipt.
Note about eSubmitter software:
Instructions provided in this software briefly summarize the requirements of the regulations under
the Federal Food, Drug and Cosmetic Act (FFDCA), Chapter V, Subchapter C - Electronic Product

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Radiation Control, that applies to manufacturers of electronic products that emit radiation. The
software provides questions relevant to requirements in the performance standards and may include
explanations or clarification about the performance, labeling, and informational requirements of the
standard. It does not replace the regulations, however, and if there is any conflict between the
software and the regulations, the regulations must prevail. Throughout this application, pertinent
sections of Title 21, Code of Federal Regulations, Chapter I, Subchapter J, are cited in parentheses.
Please consult them before making design or procedural decisions.
Regulatory requirements for radiological products can be found at http://www.fda.gov/RadiationEmittingProducts/default.htm and for medical devices are located at
www.fda.gov/M/devaDvices/default.htm. If you have specific questions about the regulations,
please contact us at: [email protected].
If you have specific questions regarding this software, please contact the eSub team by email at:
[email protected].
Thank you for using our electronic product reporting software. Please communicate your comments
and suggestions to the eSub team as often as you like.
Thank you for your continued support of the FDA Electronic Submission Program (eSub).
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB control number. The OMB control number for
this information collection is 0910-0025 (expires January 31, 2017).
Role
What is your role?
Information:

!* Manufacturer

The following screen provides several options for you to accurately define what type of
eSubmission you intend to create for FDA. Below are explanations of your options. Please
feel free to review this screen, advance to the next screen and view the picklists, but if you're
confused, come back to read this screen again to be certain you are selecting the correct
report or correspondence type you want to create.

Submission Information
Step 1

Use the radio buttons to identify the type of submission you are preparing.
(Supplements should be prepared using the same document type as the original
submission.)

What Type of Submission is this? (Supplements should be submitted
selecting the same document type as the original report.)

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!* (•) Radiation Safety

Report (Product) Report
(21 CFR 1002.10)
( ) Annual Report (21
CFR 1002.13)
( ) Laser Light Show
Documents (all relevant
documents) (21 CFR
1040.11(c))
( ) Correspondence

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( ) Variance Request
(General, not Laser Light
Show) (21 CFR 1010.4)
( ) Laser Original
Equipment/Component
Manufacturer Registration
(21 CFR 1040.10(a)(3)(ii))
( ) Abbreviated Report
(21 CFR 1002.12)
Step 2

After answering the Submission Type question above, one of the questions below
may become active and required (see the blue dot to the right of the question). If there
is an active question, select the appropriate product area or document type from the
question's pick list.

What Type of Product is this Radiation Safety Report about?

!*

Laser Products (Includes Projection Systems)
What Type of Product is this Annual Report about?
What Laser Light Show Document are you filing?
What Type of Correspondence is this?
What Type of Product is this Variance Request about?

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Manufacturer Data
Manufacturer Responsible for Product Compliance
Note:

This is the firm that takes responsibility for certification that the product meets the
performance standard. This firm develops and maintains the quality control and testing
program that is the basis for the certification of this product. Additionally, this firm usually is
the owner of the product design and manufacturing process design.
Be sure to enter address information for each tab below:

Select the Manufacturer's address from the Establishment Address book:

*

Establishment Information:
Establishment Name
Division Name
Home Page
Physical Location:
Address
Telephone Number
Fax Number
Mailing Location:
Address
Telephone Number
Fax Number

Responsible Individual
Note:

The responsible individual is the highest level and most responsible individual affiliated with
this establishment.

Select the Responsible Individual from the Contact Address book:

*

Contact Information:
Contact Name
Occupation Title
Email Address
Establishment Information:
Establishment Name
Division Name
Physical Location:
Address
Telephone Number
Fax Number

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Mailing Location:
Address
Telephone Number
Fax Number

Manufacturer's Reporting Official
Note:

This is the person at the manufacturing facility that is knowledgeable and responsible for
addressing all aspects of the testing and quality control procedures for certification as
reported to FDA in the product report. Documentation of changes intesting and quality
control procedures submitted to FDA must be signed by this individual.

Select the Reporting Official from Contact Address book:

*

Contact Information:
Contact Name
Occupation Title
Email Address
Establishment Information:
Establishment Name
Division Name
Physical Location:
Address
Telephone Number
Fax Number
Mailing Location:
Address
Telephone Number
Fax Number

Report Submitter
Note:

The submitter may be a consulting individual or firm providing assistance in report
preparation and maintenance. Documents or submissions such as this one that are prepared
by the submitter must have an accompanying authorization letter from the manufacturer's
reporting official for authenticity.

Select the Submitter from the Contact Address book:

*

Contact Information:
Contact Name
Occupation Title
Email Address
Establishment Information:
Establishment Name
Division Name

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Physical Location:
Address
Telephone Number
Fax Number
Mailing Location:
Address
Telephone Number
Fax Number
Comments:
Internal Reference Number:

Parent Establishment
Is there a parent establishment?

*

Select the Parent Establishment and Contact from the Contact Address book:
Contact Information:
Contact Name
Occupation Title
Email Address
Establishment Information:
Establishment Name
Division Name
Physical Location:
Address
Telephone Number
Fax Number
Mailing Location:
Address
Telephone Number
Fax Number

Manufacturer Designated United States Agent
Note:

Manufacturers exporting to the U.S. must designate a U.S. agent, see 21 CFR 1005.25.

Is there a United States agent that has been designated by the manufacturer?

*

Importer

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Additional Manufacturing Locations

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Product Data
Product and Model Identification

Attention - Information about this section
In this section you'll be asked to identify several required or optional things which will help
FDA/CDRH staff to prioritize their reviews. You'll be asked to consider the following aspects:
(1) Identify your product's radiation type and the CDRH Product Code.
(2) Enter an Accession number if this will be a report supplment. If you are preparing a supplement,
you'll see that after entering a valid 7-digit Accession number many questions will no longer be
required (they will either be disabled or will be optional, meaning they will no longer have the blue
dot).
(3) You will also have several questions that are of high significance for FDA/CDRH - why you
might be submitting this report or correspondence. Please read these questions carefully, referring to
the 21 CFR regulations on the website www.FDA.gov if you are unsure if the question is relevant to
your firm's situation.
(4) If you find that you have more information that you want the FDA/CDRH to read but it doesn't
seem to fit under other questions, we have a final "Additional Information" question in this section
which invites you to add comments and/or attach a file that provides further information from your
firm about this submission. This is the place to add that extra information.

Product Type Reported
What is the product code?

*

To select the three letter product code,
- Click the plus sign. You will see a product code filter dialog box.
- Select the appropriate category name from the pick list. You will be provided a list of product codes
from which to choose.
- Select the best match to your product.
- The remaining fields will be filled in for you when you select your product code.
Category
Product Code
Performance
Standard
If Other, provide a category name for this specific product.

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Report Information
Is this the first time you've submitted a report on the particular type of product selected
in the Product Type Reported section?

*

Since this is not the first time you've reported on this type of product, then is this a report
supplement to a previously reported model family?
Provide the Accession Number of the original report for which this is a supplement:
(Note: Do not enter any Device Premarket Application or Notification document number here,
such as PMAs, 510(k)s, IDEs, etc. See Accession number description below.)
Are you requesting a new variance, a renewal, extension or amendment to a
previous variance?
Stop:

*

If you are requesting a new variance, renewal, extension, or amendment, you must file a
Variance Request separate from this report. To do this, open a new report (File > New) and
select either "Laser Light Show Variance Request" or "Variance Request (General, not Laser
Light Show)" as your Type of Submission in the Submission Information Screen. If you select
"Variance Request (General, not Laser Light Show)r" you must select the product for which
you are requesting a variance with the pick list in the bottom section of the screen.

Special Considerations

Information:

If this product will require a formally approved Variance from a certain performance
requirement, you will need to complete two Reports for FDA, both (1) this Radiation Safety
Report (RSR) on this product, and (2) a Variance Request report. This eSubmitter software
application package includes a general Variance Request form as well as the specific Laser
Light Show Variance Request form. Both the Product RSR file and the appropriate Variance
Request Correspondence file must be submitted to CDRH following the regular files
packaging procedures in this application. Both may be transferred to the same CD or
submitted via the FDA ESG to submit to the FDA/CDRH.
In addition, any Variance Request form must be printed out and the signed hard-copy sent to
FDA's Division of Dockets Management at:
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane
Rockville, MD 20852
NOTE: There is no need to send a copy of the CD to Division of Dockets Management.

Noncompliances or Defects
Does this document or any of its attachments contain:
A notification of noncompliance or defect?

*

You may provide an explanation and/or attach a document here:
Details

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Responses to Noncompliances or Defects
Does this document or any of its attachments contain any of these responses concerning
noncompliances or defects?
A refutation of noncompliances or defects identified to your firm?

*

A request for an exemption from notification to purchasers (see 21 CFR 1003.21 and 1003.30)?

*

Corrective action plans you intend to implement to correct noncompliances or defects discovered in
past or current production?

*

Note:

If you are submitting a Corrective Action Plan (CAP) following 21 CFR 1004 and information
on design changes for future production, the design change information must be submitted in
a Radiation Safety (Product) Report or supplemental report. Both the proposed CAP and the
design changes may be submitted in one document if you prepare a product report and
choose to include the CAP in it as a file attachment. Alternatively, you may create a separate
eSubmission for the CAP using the "Correspondence" type template and selecting "Followup correspondence to FDA."

A description of any design changes that correct noncompliances for future production?
Note:

*

If you are submitting information on product design changes for future production due to a
discovery of noncompliances or defects in current production, you must use the Radiation
Safety (Product) Report template to create the report . Correspondence templates may be
used to submit other information such as a proposed corrective action plan pertaining to a
noncompliance or defect.

You may add an explanation and/or attach a document here:
Details

Exemption Requests
Does this document or any of its attachments contain:
Exemption of a product for government use from a standard (21 CFR 1010.5)?

*

Exemption for products for government use from reporting and recordkeeping (21 CFR 1002.51)?

*

Special exemption of products from reporting and/or recordkeeping (21 CFR 1002.50)?

*

Request for approval of alternate labeling?

*

Application for alternate test procedures (21 CFR 1010.13)?

*

You may provide an explanation and/or attach any relevant documents here:

Variance Requests
Information:

Please note: in addition to responding to these questions below, a separate General
Variance Request or Laser Light Show Variance Request form must be completed and
submitted to CDRH, with a hard copy sent to FDA's Division of Dockets Management as
instructed below for any variance request. The information requested on this screen does not
constitute the full structured content of the variance request. The 2 types of Variance forms
can be created in eSubmitter by selecting the appropriate Variance submission type under
the eRad Health Menu section of this application.

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Click the plus sign to list the requirements from which you are requesting a variance.

This submission includes an application for a variance from certain requirements.
Item

No Information Provided.

Provide an explanation and attach supporting files, if necessary. Click on the plus sign below to attach files.
Details
Stop:

For all Variance requests, two submissions must be made to the FDA.
The electronic version should be submitted following the Packaging Files for Submission
instructions located under Output in the Menu bar, and explained in subsection 4.3 of the
User Manual. If sending a CD & submittal letter, please mail to:
U.S. Food and Drug Administration
Center for Devices and Radiological Health
Attn: eSubmitter Team
Document Mail Center - WO66-0609
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
Additionally, a paper version (hard-copy) of the signed Variance request document should be
submitted to:
Food and Drug Administration
Division of Dockets Management (HFA-305)
5630 Fishers Lane, Room 1061
Rockville, MD 20857

Responses to Communications from FDA
Does this document or any of its attachments contain:
A response to an FDA inspection?

*

What was the date of the inspection?
A response to a Warning letter or a Notification of Noncompliance or Defect from the
FDA?

*

What was the date of the Warning Letter or other notification letter?
A response to a report review inquiry from the CDRH (the inquiry may have been in the
form of a letter, email, or phone call)?

*

What was the date of the inquiry?
A response to any other communication from FDA?

*

What was the date of the communication?
Provide an explanation:

Additional Information
Here's your opportunity to add anything else to this submission that you want to tell the FDA!

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Is there any other relevant information or additional comments that would help expedite the review of this
submission? Click the plus sign below to attach any supporting files.
Details

Private Labeling
Is the product sold by other companies under different brand names?

*

Medical Devices
Provide the premarket 510(k), IDE, HDE, PDP, or PMA filing numbers related to this medical product, if one
of these numbers has been assigned by FDA yet.

If it has not been submitted yet, or if your device is exempt from premarket clearance or approval, please
provide an explanation. The device regulations can be found in 21 CFR 807 - device manufacturer
registration and device listing.

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Laser Product
PART 1: DEFINITIONS

GENERAL DEFINITIONS
This software application should be followed for all lasers and products containing, incorporating, or
intended to incorporate, a laser or laser system [see the definition of "laser product" in section 21
CFR1040.10(b)(21)]. A separate form for reporting additional information concerning laser light
shows is being published concurrently with this form and must be used in conjunction with this form
when appropriate (Reporting Guide for Laser Light Shows and Displays).

Laser Reporting and Recordkeeping (21 CFR 1002)
Applicability of reporting and recordkeeping requirements for laser products:
Class I, IIa, II, and IIIa laser products and laser products containing such lasers will require:
Product Report, Annual Report, test records,manufacturer's distribution records, and
dealer/distributor distribution records.
Note that for Class I laser products containing lasers of Class I, IIa, II, or IIIa no Supplemental
Reports are required. Furthermore, some Class I laser products have already been exempted from
the requirement for distribution records (see Notice to Industry dated August 9, 1988, Laser
Notice # 41).
Class IIIb and IV laser products require all of the above plus Supplemental Reports when the
criteria requiring submission of Supplemental Reports are met.
The laser standard applies to all laser products manufactured after August 1, 1976 (1040.10(a)),
unless the products are either: sold to a manufacturer for use as components (or replacements) in
products that will be certified (1040.10(a)(l)); sold by or for a manufacturer as repair or replacement
components if they are properly labeled as such and have installation instructions (1040.10)(a)(2));
or intended for export only, are labeled as such, and comply with the requirements of the importing
country (1010.20). Manufacturers of laser products that are sold to other manufacturers for use as
components in their products are required to register and list such products.

Laser Definitions from 21 CFR 1040.10(b)
Laser means any product that can be made to produce or amplify electromagnetic radiation at
wavelengths greater than 250 nm but less than or equal to 13,000 nm or, after August 20, 1986, at
wavelengths equal to or greater than 180 nm but less than or equal to 1.0 x 10 to the power of 6 nm
primarily by the process of controlled stimulated emission.
Laser energy source means any product intended for use in conjunction with a laser to supply
energy for the operation of the laser. General energy sources such as electrical supply mains or
batteries shall not be considered to constitute laser energy sources.

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Laser product means any manufactured product or assemblage of components which constitutes,
incorporates, or is intended to incorporate a laser or laser system. A laser or laser system that is
intended for use as a component of an electronic product shall itself be considered a laser product
(1040.10(b)(21)).
Laser radiation means all electromagnetic radiation emitted by a laser product within the spectral
range specified in paragraph1040.10(b)(19) that is produced as a result of controlled stimulated
emission or that is detectable with radiation so produced through the appropriate aperture stop and
within the appropriate solid angle of acceptance, as specified in 1040.10(e).
Laser system means a laser in combination with an appropriate laser energy source with or without
additional incorporated components. See paragraph 1040.10(c)(2) of the laser product performance
standard for an explanation of the term "removable laser system."

Specific-Purpose Products
Medical laser product means any laser product which is a medical device as defined in 21 U.S.C.
321(h) and is manufactured, designed, intended or promoted for in vivo laser irradiation of any part
of the human body for the purpose of: (i) Diagnosis, surgery, or therapy; or (ii) relative positioning
of the human body. Class IIIa, IIIb, and IV medical laser products must contain a means for
measuring the delivered exposure or treatment level of radiation, accurate within plus or minus 20
percent. This requirement is not applicable to Class IIIa aiming devices except ophthalmic
application.The instruction manual must include a procedure and schedule for recalibration of the
measurement system. A modified aperture label is also specified (1040.11(a)).
Surveying, leveling, or alignment laser product means a laser product manufactured, designed,
intended or promoted for one or more of the following uses:
(i) Determining and delineating the form, extent, or position of a point, body, or area by taking
angular measurement.
(ii) Positioning or adjusting parts in proper relation to one another.
(iii) Defining a plane, level, elevation, or straight line.
Surveying, leveling, and alignment laser products are generally used in agriculture and in the
construction industry. They are restricted to 5mW visible radiant power and to Class I for other
wavelengths and pulses less than 3.8 x 10 to the power of negative 4 seconds (1040.11(b)).
Demonstration laser product means any laser product manufactured, designed, intended, or
promoted for purposes of demonstration, entertainment, advertising display, or artistic composition.
The term "demonstration laser product" does not apply to laser products which are not
manufactured, designed, intended, or promoted for such purposes, even though they may be used for
those purposes or are intended to demonstrate other applications. Demonstration laser products
(1040.10(b)(13)) include:
laser products promoted for classroom demonstration of optical phenomena;
artistic displays and their associated apparatus;

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laser light show projectors; and
laser light shows and displays themselves.
A general-purpose, scientific, medical or industrial laser product is not considered to be a
demonstration laser product when it is demonstrated to a prospective purchaser. Demonstration laser
products are restricted in their outputs to Class IIIa with its accompanying restrictions to Class I for
short pulses and invisible wavelengths(1040.11(c)). Because these levels are too low for effective
use in commercial theatrical lighting effects, CDRH may grant variances (1010.4) to manufacturers
of laser light shows and display devices. As a condition of the variance, the manufacturer must agree
to adhere to several safety conditions to provide a level of safety to the public equivalent to a fully
compliant product. Consult the Compliance Guide for Laser Products, September 1985, Appendix
B, Clarification of Certain Laser Light Show Requirements, for more information.
PART 2: PRODUCT AND MODEL IDENTIFICATION

! Attention !
In the following sections of the report template you will see references to
"Laser Notice #NN" and the "Compliance Guide for Laser Products.'" You can
find these documents and other information relating to laser products on the
page Laser Products and Instruments.
On the Laser Products page you can click on the button link at the top, right
side of the page Notices to the Laser Industry and you will be taken to the
page which lists links to the Laser Notices and the Compliance Guide for
Laser Products sorted in date order.
The Compliance Guide itself may be found at this link: Compliance Guide for

Laser Products (FDA 86-8260)

2.1 Model Designation
Note:

Report the model name and/or number, model family, brand name, or other designation of
the product. If reporting a model family, provide the model designation of each model. If you
do not use a model family or brand name, leave the field blank.

Model Designation (Names and/or Numbers):
Item

Model Name

Family Name

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*
Brand Name

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2.2 Approval of Alternate Means
Does this document or any of its attachments contain:
An application for approval of alternate means of providing the equivalent or superior protection that a
required performance feature or labeling would provide (this is applicable to the beam attenuator
requirements and alternate labeling)?

*

What requirement are you requesting an approval of alternate means from?

Provide an explanation:

2.3 Product without a Laser
Is it a product that does not incorporate a laser but is intended to incorporate a laser?

*

If the product as introduced into commerce does not incorporate a laser, identify the manufacturer and
models of the laser that you recommend:
Item

No Information Provided.

Is it a product that is intended to be used with a laser?

*

If the product as introduced into commerce is intended to be used with a laser, identify the manufacturer and
models of the laser that you recommend:
Item

No Information Provided.

If your product does not incorporate a laser or you do not recommend a specific laser for use with the
reported product, state the specifications of the laser or laser system which may beincorporated in or used
with your product. This would include wavelengths, power or energy levels, etc.

2.4 Modification of a Laser Product
Note:

Modification involves any changes to the product that affect its classification, performance or
labeling requirements (as required by the standard or an approved variance).

Is your laser product the result of the modification of a laser product certified by another
manufacturer?

*

2.5 Incorporation of Unmodified, Certified Laser Product

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Does your laser product incorporate an unmodified, certified laser product?

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*

2.6 Incorporation of Uncertified Laser Product
Does your laser product incorporate an uncertified laser product as a component or component
subsystem?

*

2.7 Incorporation of Removable Laser System
Does your laser product incorporate a removable laser system or systems as defined by 21 CFR
1040.10(c)(2)?

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*

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Technical Data
PART 3: DESCRIPTION OF THE PRODUCT
Note:

In this section, you are asked to provide descriptions of the product, its intended function,
and the laser radiation fields or paths and collateral radiation that may be accessible in
operation, maintenance, or service modes of the product. This section was previously Part 5
of the product reporting guide.

3.1 Product Description and Function
Note:

You may refer to brochures and manuals submitted as attachments to this report.

Describe the product and its function:

*

Details

3.2 External and Internal Laser Radiation Fields and Paths
Note:

Include beam path diagrams indicating protective housing, beam attenuators, viewports,
scanners, targets, etc. Indicate energy and power levels at locations inside and outside the
product.

Describe the external and internal laser radiation fields and paths:

*

3.3 Operational Procedures and Accessible Radiation
Note:

Describe here the procedures used during operation and the laser or collateral radiation that
is accessible during these procedures.

List the procedures performed during operation:

Do these procedures provide human access to ANY laser or collateral radiation?

*

*

Do the levels of laser or collateral radiation exceed the limits of Class I or Table VI?
Indicate those collateral and laser radiation fields to which human access is possible during those operation
procedures. Include the locations and identifications of laser and collateral radiation made accessible by
viewing optics, viewports, and display screens:

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3.4 Maintenance Procedures and Accessible Radiation
Note:

Describe here the procedures used during maintenance and the laser or collateral radiation
that is accessible during these procedures.

List the procedures performed during maintenance:

*

Do these procedures provide human access to laser or collateral radiation levels in excess of Class I
or Table VI?

*

Indicate those collateral and laser radiation fields to which human access is possible during those
maintenance procedures:

*

3.5 Service Procedures and Accessible Radiation
Note:

Describe here the procedures used during service and the laser or collateral radiation that is
accessible during these procedures.

List the procedures performed during service:

*

Do these procedures provide human access to laser or collateral radiation levels in excess of Class I
or Table VI?

*

Indicate those collateral and laser radiation fields to which human access is possible during those
service procedures:

*

PART 4: CERTIFICATION, CLASSIFICATION, AND LEVELS OF RADIATION
Note:

This section, covers the description of the certification and identification labels and the
detailed explanation of your classification of the product.

4.1 Performance Standard Identification
With which performance standard does your product comply?

*

4.2 Certification Label
Note:

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Required by the CDRH standard and Laser Notice #50 for all laser products regardless of
whether the CDRH laser standard or the IEC laser standard is being used for other
requirements..
Is a certification label present on your product?

*

Does your certification label state that the product complies with the FDA performance standards except for
deviations pursuant to Laser Notice #50, dated July 24, 2007?
Attach a copy of the certification label with an indication of its location on the product:

*

4.3 Identification Label
Note:

Required on all laser products.

Attach a copy of the identification label with an indication of its location on the product:

4.4 Performance Standard Classification
Under which laser product performance standard are you classifying your product?

*

4.5 Laser Product Class
Indicate the Class of the Laser Product:

*

4.6 Operation
Note:

For classification purposes describe the radiation levels accessible in any of the operational
configurations of the product.

4.7 Embedded Laser System
Note:

Describe here laser radiation fields contained within the protective housing of the product
which may exceed the class of the product. The classification of the contained laser radiation
is pertinent to safety interlock and protective housing label requirements.

4.7.1 Internal Radiation Levels
Does the protective housing contain radiation in excess of the Class of the product (such as in a
product that has a higher class laser embedded inside, such as a laser printer or workstation)?

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*

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4.8 Maintenance
Note:

Describe here the laser radiation fields accessible in maintenance configurations of the laser
product.

4.9 Service
Note:

Describe here the laser radiation fields accessible in service configurations of the laser
product.

4.10 Collateral Radiation
Describe all collateral radiation fields associated with the product. Report the source(s) and levels and
describe where and under what circumstances such radiation is accessible:

*

Provide a diagram of yourmeasurement set-up or the analysis used in your calculations. Provide
pertinent dimensions such as separation distances, source and detectoraperture size, etc. to show
compliance with the standard under which you are classifying:

*

PART 5: COMPLIANCE WITH PERFORMANCE REQUIREMENTS
Note:

In this section, you will describe how your product complies with the performance
requirements. This section was previously Part 7 of the product reports.

5.1 Protective Housing
Note:

Required for all classes of laser products (see 1040.10(f)(1) and Compliance Guide).

Describe the product's protective housing and how it serves to prevent unnecessary human access to
levels of laser radiation in excess of Class I:

*

Describe how the protective housing prevents access to unnecessary collateral radiation in excess of
Table VI:

*

5.2 Safety Interlocks
Note:

Applicable for all Classes of laser products (see 1040.10(f)(2)(i) and Compliance Guide).

Does your product have portions of the protective housing that are intended to be opened or removed
for:

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Operation:
Maintenance:
Service:
Does your laser product incorporate any safety interlocks?
What types of interlocks (select all that apply):
Item

No Information Provided.

If other, then please specify:
Provide an electrical block diagram illustrating the logic of all interlock systems:

Provide a detailed mechanical diagram showing where they all are located on the product:

5.3 Remote Interlock Connector
Note:

Applicable to Class IIIb or IV (and IEC:3B and 4) laser systems (see 1040.10(f)(3) and
Compliance Guide).

Does the product have a remote interlock connector that disables the laser radiation when the circuit is
open?

*

Describe the electrical and mechanical construction and operation of the remote connector (give its circuit
and physical location):

Record the open-circuit electrical potential difference between the terminals of the remote interlock connector:

5.4 Security Master (Key) Control
Note:

Required for Class IIIb or IV (and IEC:3B or 4) laser systems (see 1040.10(f)(4) and
Compliance Guide).

Does your product have a Security Master control?

*

What type of security control is it?
If other, then please specify:
Describe how it works,including how the key control prevents unauthorized use of the product:

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Is the key control removable in the "On" position?
Describe the function of the key control and how it renders the laser inoperable when the "key" is removed:

5.5 Laser Radiation Emission Indicator
Note:

Required for Class II, IIIa, IIIb, or IV (and IEC: 3R, 3B, and 4) laser systems (see 1040.10(f)
(5) andCompliance Guide).

Does the product incorporate any emission indicators?

*

Describe in detail the mechanical and electrical characteristicsof all emission indicators installed pursuant to
Section 1040.10(f)(5)(i) or (ii) and give their locations:

What type of emission indicator is incorporated?
If "other", please describe:

How is your emission indicator warning fail-safe or redundant?

5.6 Beam Attenuator
Note:

Required for Class II, IIIa, IIIb or IV (and IEC: 3B or 4) laser systems (see 1040.10(f)(6) and
Compliance Guide).

Note:

You may be able to use currently approved alternate means or you may need to apply for
approval of alternate means of providing this protection if this alternate means provides
protection equivalent to a beam attenuator.

Does your product have a beam attenuator?

*

Does your product have an alternative?
Describe or attach request for approval of alternate means:

5.7 Location of Controls

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Applicable to Class II, IIIa, IIIb or IV laser products (see 1040.10(f)(7) and Compliance
Guide).

Are operational and adjustment controls located so that exposure to laser radiation, above the
accessible emission limits of Class I and Table VI, is unnecessary?

*

Describe:

5.8 Viewing Optics
Note:

Applicable to all laser products (see 1040.10(f)(8)and Compliance Guide).

Does the product incorporate any of the following viewing optics:

*

If so, please further describe the viewing optic that is incorporated:

Is the laser and collateral radiation that is accessible by virtue of viewing optics,
viewports, or display screens less than the accessible emission limits of Class I
and Table VI during operation and maintenance?
Provide calculations and/or measurements,including pertinent attenuation factors, window transmission
characteristics, etc.:

5.9 Scanning Safeguard
Note:

Required for certain laser products with scanned laser radiation (see 1040.10(f)(9) and
Compliance Guide).

Note:

A safeguard is required when scan failure would cause the product to exceed the emission
limits of its class.

Does the product incorporate a scanning safeguard?

*

Describe the mechanical, electrical, and functional characteristics of any required scan failure safeguard:

Is the classification of the product based on the level of scanned radiation?
What is the reaction time?

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Provide calculations to show that the safeguard's reaction time is adequate to prevent human access to laser
radiation in excess of the product's class:

5.10 Manual Reset
Note:

Applicable to Class IV laser systems manufactured after August 20, 1986. (see 1040.10(f)
(10) and Compliance Guide).

Does the product incorporate a manual reset mechanism or means that prevents automatic restart
following interruptionof emission caused by power failure of at least 5 seconds or deactivationthrough
the remote interlock connector?

*

Provide the circuit and physical description and location of the manual reset mechanism:

Does emission delay reactivate when power is resumed after an interruption of 5 seconds or more?
Must the emission be manually restarted following interruption via the remote interlock connector?

5.11 Medical Laser Product
Note:

Applicable to Class III or IV (and IEC: 3B or 4) medical laser products intended for in-vivo
surgical, therapeutic, or diagnostic irradiation of the human body (see 1040.11(a) and
Compliance Guide).

Note:

The requirement in section 1040.11(a) does not apply to visible aiming beams less than the
accessible emission limits of Class IIIa except for ophthalmic indications.

Describe the means incorporated into the product to measure the level of laser radiation intended for
irradiating the human body; include circuit diagrams and/or optical system diagrams:

5.11.1 Laser Radiation Levels
Is the radiation level continuously monitored?
Explain how the radiation level is monitored:

Describe how the system can assure the accuracy of the displayed value to within 20%:

5.11.2 Measurement and Monitoring Uncertainties

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Specify the uncertainty in the measurement system and describe the method by which it was derived:

Specify the uncertainty in the monitoring system and describe the method by which it was derived:

Describe how the displayed power/energy level is either measured at the point of delivery or measured earlier
and then the actual output calculated:

If the displayed level is calculated, then provide calculations incorporating system constants, losses,
attenuation factors, etc. to demonstrate accurate calibration of the delivered beam to +/-20%:

5.11.3 Calibration Procedures
Note:

A procedure for calibration of the means for output measurement is required by the CDRH
laser standard. However, if your medical laser product complies with IEC 60601-2-22 and
you prefer to certify following Laser Notice #50, the IEC standard requires instructions for a
calibration verification of the output beam.

Are procedures and a schedule for recalibration of the measurement system included in the user
instructions? If you are using the IEC 60601-2-22 standard for medical laser products in accordance with
Laser Notice 50, do you provide instructions for doing a calibration verification of the output beam?
Identify location in the user instructions:

5.12 Surveying, Leveling, or Alignment Laser Products
Note:

As a surveying, leveling, or alignment laser product it is subject to the requirements of
section 1040.11(b).

Note:

If the product's class exceeds CDRH Class IIIa or IEC Class 3R or is IEC Class 1M or 2M,
then an approved variance from the performance requirements in this section would be
necessary prior to introduction into commerce.

Is a variance request being submitted with this report?

5.13 Demonstration Laser Products
Note:

As a demonstration laser product it is subject to the requirements of section1040.11(c).

Note:

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If the product's class exceeds CDRH Class IIIa or IEC Class 3R or is IEC Class 1M or 2M,
then an approved variance from the performance requirements in this section would be
necessary prior to introduction into commerce.
Note:

An Application for a Variance from 21 CFR 1040.11(c) for a Laser Light Show,Display, or
Device (form FDA 3147) must be submitted, following the instructions on the form. A Laser
Light Show Report may also be required for Class IIIb or IV shows or displays.

Note:

You may prepare all these reports and the variance request together using eSubmitter and
transfer them all to a single CD to ship to CDRH, if that's the preferred method of submitting.
If you do this you need to remember that during packaging of each submission you must
print and sign each submittal letter, then send each letter (either scanned & attached
following the packaging instructions or just inserted into the envelope with the CD).

Is a Laser Light Show report being submitted along with this report?
Is a variance application for a laser light show projector and laser light show being
submitted along with this report?
Does its user instructions include a warning not to direct the laser radiation at the
audience?

PART 6: COMPLIANCE WITH LABELING REQUIREMENTS
Note:

In this section, you will describe how your product complies with the labeling requirements.
This section was previously Part 3 of the product reporting guide.

Note:

For each of the following labels required for the product being reported, provide a sample or
a facsimile of each label. Clearly indicate the locations on the product of allrequired labels.
Submitting diagrams, photographs, blueprints, product literature, etc. is acceptable (see laser
notices # 16, 17, 45, and 50).

6.1 Performance Standard Identification
With which performance standard do your product's labels comply:

*

6.2 Warning Logotype Label
Note:

Required on Class II, III, and IV laser products. (see 1040.10(g)(1), (2),(3),(4),(8),(9),(10) and
Compliance Guide).

Attach a copy with an indication of its location on the product:

6.3 IEC Warning Label
Note:

Required on all Class 1, 1M,2, 2M, 3R, 3B, and 4 laser products.

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Attach copies of both the warning label (hazard symbol) and the explanatory label with an indication of
their locations on the product. If the radiation output and the standard used are not stated on the
explanatory label, then a copy of the label giving this information and its location on the product must
also be attached.

*

6.4 Class IIa Warning Label
Note:

Required on Class IIa laser products (see 1040.10(g)(1)(i) and Compliance Guide).

Attach a copy with an indication of its location on the product:

6.5 Aperture Label
Note:

Required on Class II, III and IV (IEC: 3R, 3B, and 4) laser products (for nonmedical laser
products see 1040.10(g)(5),(8),(9),(10) or for medical laser products see 1040.11(a)(3) and
Compliance Guide).

Attach a copy with an indication of its location on the product:

6.6 Protective Housing Labels
Note:

See 1040.10(g)(6),(7),(8),(9),(10), Compliance Guide, and Laser Notice 17.

Does your product have any protective housing labels?

*

Does your product have any noninterlocked protective housing labels?
Attach a copy with an indication of its location on the product:
Indicate how the label(s) are visible both prior to and during opening or removal of housing:

Does your product have any defeatably interlocked protective housing labels?
Attach a copy with an indication of its location on the product:
Indicate how the label(s) are visible both prior to and during interlock defeat:

Does your product have any optionally interlocked protective housing labels?
Attach a copy with an indication of its location on the product:

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Indicate how the labels are visible both prior to and during opening or removal of the housing:

PART 7: COMPLIANCE WITH INFORMATIONAL REQUIREMENTS
Note:

In this section, you will describe how your product complies with the informational
requirements. This section was previously Part 4 of the product reporting guide.

7.1 User Information
Submit a copy of user information (operator's manuals) for your laser product. If the manual is very
extensive, submit those portions that confirm compliance with Section 1040.10(h) [and 1040.11(a)(2), if
a medical laser product]:

Does the manual contain adequate instructions for assembly, operation, and
maintenance?

*

Does it contain clear warnings to avoid exposure?

*

Does it contain a statement of output parameters?

*

Does it contain legiblereproductions of all labels, their locations on the product,
and hazard warnings?

*

Does it contain a listing of controls, adjustments, and procedures for operation
and maintenance?

*

Does it contain a schedule of maintenance?

*

Does it contain the "Caution - use of controls..." warning statement?

*

Does it include information to determine nominal hazard zone for users?

*

Does it contain a compatibility statement concerning recommended lasers or
specifications?

*

Does it contain an additional warning stating that viewing the laser output with
optical instruments may result in an eye hazard for Class 1M or an increased
hazard for Class 2M?

*

Note:

*

These materials may also have been used in the product description required by Part 3.

7.2 Promotional Literature
Submit copies of any sales literature, including catalogs, specification sheets, and descriptive brochures
for Class IIa, II, III, and IV laser products:

*

Note:

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This material is needed to demonstrate compliance with Section 1040.10(h)(2), which states
that a reproduction of the warning logotype is required in all catalogs, specification sheets,
and descriptive brochures.

7.3 Servicing Information
Submit a copy of the relevant radiation safety sections of your product's servicing information (from your
service manual):

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Quality Control
PART 8: PRODUCT DESIGN VERIFICATION
Note:

In this section, any attached files must identify the manufacturing facility and name of the
responsible Quality Assurance manager for the activity. This section waspreviously Part 9 of
the laser product reporting guide.
In this section, you will also describe those design considerations, verification activities, and
controls implemented to ensure that the reported product will remain in compliance with the
Federal laser product performance standard during its useful life.
Quality control and product testing should be based on design considerations and factors
that can affect product compliance with the Federal laser product performance standard.

8.1 Critical Design Requirements
List the factors identified during design that may provide product compliance with the Federal laser
product performance standard or performance as related to accessible or emitted laser radiation (e.g.
performance specifications, component selection):

*

8.2 Life Testing
Note:

In this section you will describe those verification activities conducted to assure product
compliance with the Federal laser product performance standard over its useful life.

Note:

Maintenance and/or service instructions must include schedules for maintenance and
replacement of components that may be necessary for the compliance of the product during
its useful life.

Testing of features designed to meet Federal laser product performance requirements:

*

Acceptance of electrical and electronic components:

*

Dimensional stability and rigidity of mechanical parts and assemblies such as housings and mounts:

*

Environmental stability of components such as filter materials, coatings,and adhesives:

*

Other factors that might affect your product's radiation safety:

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Provide an estimate of the useful life of the product (in years):

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*

8.3 Change Controls
Describe the controls implemented to assure compliance with the Federal laser product performance
standard (e.g. control of design changes, user and service information changes, labeling changes to
assure that compliance of the product is not jeopardized.):

*

PART 9: QUALITY CONTROL TESTS AND PROCEDURES
Note:

In this section, any attached files must identifythe manufacturing facility and name of the
responsible Quality Assurance manager for the activity. This section was previously Part 8 of
the laser product reporting guide.
Section 1010.2(c) requires that certification be based on a test, in accordance with the
standard, of each unit or on a program in accordance with good manufacturing practices.
Failure to maintain an adequate testing program may result in disapproval of the program by
CDRH.

9.1 Quality Control Documentation
Note:

Attach samples of documents that describe, specify, or relate to procedures or tests used to
ensure compliance of your reported product with the standard, including compliance with all
performance, labeling, and informational requirements.

Specification controls for critical components:

Manufacturing and assembly control procedures:

Inspection and test control procedures:

Assembly and test traveler forms:

Inspection and test reports and checklists:

Other(s), specify:

9.2 Alternate Quality Control Procedures

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If formal quality control and testing procedures have not been implemented or are not sufficient to assure that
your product(s) will comply with the standard, explain how you assure that your products comply and submit
supporting documentation:

PART 10: INSTRUMENTATION AND CALIBRATION
Note:

In this section, you will describe the instrumentation used for compliance testing your product
and the instrumentation calibration procedures.

10.1 Component Testing
Do you purchase components or services from contractors or original equipment manufacturers in lieu of
conducting your own in-house testing?
Provide certificates or sample test/inspection records from suppliers or original equipment manufacturers, etc.
to assure that those entities are operating in a state of control.

Describe those tests and controls used to determine whether the reported product is producedto be in
compliance with the Federal laser product performance standard:

Do you conduct in-house compliance testing for your product?
Do you have testing done by an outside contractor?

*

10.2 Compliance Testing
Describe those tests and controls used to determine whether the reported product is produced to be in
compliance with the Federal laser product performance standard:

*

List the instruments you use to determine compliance of the reported product with the standard.
Describe these instruments or provide copies of specification sheets. Identify each detector's aperture
size, if applicable.

*

Indicate how the measurement system collects or accounts for the total radiant energy or power
specified in Section 1040.10(e):

*

Provide a measurement error analysis (for all sources of error identified) and an uncertainty statement for all
measurement data reported. (If it isclear from the measurement data, including the total estimated

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uncertainty, that the levels are well below the applicable class limit, then an error analysis and uncertainty
statement are not required. For example, an error analysis and uncertainty statement would not be required
for a 1.5 milliwattHeNe laser product classified in Class IIIa.):

10.3 Calibration
Provide instrument calibration schedules and indicate how your instruments are calibrated (e.g.,calibrated by
your company against a working standard, returned to the manufacturer of the instrument, sent to an
independent calibration laboratory) [If your laser product operates at a level closely approaching a specified
limit, high accuracy and traceabilty to the National Institute of Standards and Technology (previously known
as the National Bureau of Standards) are important]:
Stop:

You have reached the end of this report. Please verify that all PDFs that are to be included in
this submission are correctly attached to a specific file attachment question. Otherwise, they
will not be packaged with your report. Check to make sure you have no missing data (select
Missing Data Report from the Output menu). Once you have confirmed that there is no
missing data and all your files are attached, click on the Package Submission icon on the
tool bar.

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