FDA 3640 Laser Light Show (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 Light Shows
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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Message:

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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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Report Identification
1.0 General 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)].

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 1.0X106 nmprimarily by the
process of controlled stimulated emission.
Laser energy source means any product intended for use inconjunction 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.
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 product is any device that

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constitutes, incorporates, or is intended to incorporate a laser or laser system (1040.10(b)(21)). A
laser or laser system that is intended for use as a component of an electronic product shall itself be
considered a laser product.
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."

2.0 Specific-Purpose Product Definitions

Specific-Purpose Product Definitions
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;
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 invisiblewavelengths(1040.11(c)). Because these levels are too low for effective use
incommercial 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 publice quivalent 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.
3.0 Show Name
What is (are) the name(s) of the light show or display?
Item

Show Name

Projector Model

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*
Brand or Trade Name

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4.0 Variance
Attach a copy of your variance application (FDA Form 3147) and/or, if approved, attach your variance
approval letter (or variance number). Click on the Add... button below to attach any supporting files.

*

»

Is variance application attached?

*

»

Is a copy of your variance approval letter attached?

*

»

Or provide current variance number:

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Equipment Information
5.0 Projection Equipment
6.0 Show Venue
The laser light show or display takes place in:
Item

*

No Information Provided.

»
Note:

If "other" has been selected, please specify:
Be sure to provide beam path diagrams/floor plans for each of the types of venues listed
above, unless certain drawings are general enough to cover more than one type. Drawings
shall be attached following Part 9.0 Diagrams and Drawings of Show Venue.

The laser light show or display takes place:
Item

*

No Information Provided.

»

If "other" has been selected, please specify:

7.0 Show Locations, Dates, and Times
Note:

Give specific location(s), date(s), and time(s) for the show if this information is known at the
time this report is submitted. If not, advanced written notification must be made as early as
possible to appropriate Federal, State, and local authorities. To be considered timely, this
written notice must be submitted 30 days prior to the opening of the show. When the show
dates become known to the manufacturer less than 30 days prior to the show date, the
required information must be provided verbally by phone or by FAX to CDRH. A confirming
formal written notice, including the date of the phone notification and the name of the CDRH
individual to whom the information was given must be submitted within 14 days. Written
confirmation would not be needed following a FAXed notification. CDRH must be notified of
every show that your firm intends to produce. If notifications are not routinely received in a
timely manner your variance may be revoked.

Click on the Add... button below to attach any supporting files.

*

Details

8.0 Light Show Effects Produced
The laser light show uses the following laser effects:
Item

*

No Information Provided.

If "other" has been selected, please specify:
Note:

Be sure that the beam path diagrams included in your response to Part 9.0 are sufficient to
illustrate all of the effects indicated above. Several effects may be included in a single
diagram.

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9.0 Diagrams and Drawings of Show Venue
9.1 Provide both plan and elevation drawings with dimensions of the show or display. If the setup varies
from show to show, then provide this information for a typical show. * If no drawings are attached,
please add an explanation in the text box. Click on the Add... button below to attach any supporting
files.

*

*Be sure to include in the drawings:
(1) the location of the projector(s) and control panel(s), audience, performer(s), operator
(s), mirrors, mirror balls, display screens (or other targets), and beam termination points;
(2) the direct and reflected laser radiation beam path;
(3) the laser radiation levels in each beam including the wavelength, maximum power,
and scan parameters (if scanned) for the worst case from a human access point of view;
(4) the minimum separations of the laser radiation fields (or beams) from reference
locations in audience and performer areas in both vertical and horizontal directions; and
(5) any direct or reflected beams into audience or performer locations.
Are drawings attached?

10.0 Laser Radiation Levels
10.1

Describe how each of the laser radiation levels, indicated on the drawings attached in 9.0, were
determined. If any levels were derived from calculations rather than directly measured, provide
the actual calculations that were made. Click on the Add... button below to attach any
supporting files.

*

11.0 Scanning Safeguards
11.1

Will there be audience scanning* from any of the planned effects?

Note:

11.2

* Audience scanning is considered to be any scanning, projection, or reflection of laser or
collateral radiation into audience or other accessible, uncontrolled area. Scattered radiation
coming from diffuse reflectors such as fog, smoke, mist or similar diffusing media is not
considered audience scanning. However, all radiation must be below Class I levels if it
reaches into audience or other uncontrolled areas. A scanning safeguard is required
whenever a laser light show includes audience scanning to assure that the laser radiation
levels in audience areas will not exceed Class I limits if there is a scan failure. See the
companion publication, "Compliance Guide for Laser Products," for further discussion.
Do any of the planned effects require laser radiation (direct or scanned beams) to be viewed
by operators, performers, or employees?

»

*

*

If the answer to 11.1 or 11.2 is yes, describe how the radiation levels that reach into audience areas
are maintained at Class I levels by scanning. Your attached description must include details of the
required scan failure safeguard, including a discussion of the means of detection of the scanning, the
theory of the operation of the scanning safeguard, and its speed of response in order to show that it
will prevent the scanned radiation from exceeding the Class I limits.

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11.3

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Will any laser radiation greater than Class I STRIKE BUT NOT BE VIEWED by operators,
performers or other employees?

»

*

Describe, in detail, the operation of the scan failure safeguard or other means which will prevent
exposure to beams exceeding Class II. If a scan safeguard is used, include a discussion of the
detection of scanning, the operation, and the speed of response of the safeguard to show that it will
prevent the scanned radiation from exceeding the limits of Class II. If other means are used, such as
pressure pads or infared beams, describe in detail as well.
Details

12.0 Operator Controls
12.1

Is the show under the continuous control of an operator?

12.2

Does the laser operator perform tasks in addition to operation of the laser projector?

»

12.3

*

Describe those tasks:

Can the operator see all of the propagating beam paths, their terminations and the audience at all
times during the performance?

»

12.4

Explain how adequate surveillance is provided:

Do any other personnel assist in providing surveillance of the laser display?

»

State the number of persons, their identification (job titles), their duties, and how they assist in
providing surveillance. Describe how they are in constant communication with the operator.

What qualifications* are required of laser operators for your show?
Note:

12.6

* Holders of variances are required by the variance to employ trained operators or to assure
that the operators receive adequate training to qualify them for the safe use of the laser
projection system and presentation of the light show effects. Useful information including
training films, reference books, and programs on the safe use of lasers may be obtained
from the Laser Institute of America (LIA) and from the American National Standards Institute
(request ANSI standard Z136.1).
If your show is not under the continuous control of an operator, is a person designated to be
responsible for the immediate termination of the laser radiation in the event of equipment
malfunction, audience unruliness, or other unsafe conditions?

»

Explain alternate control:

12.7

How is this person designated? What are his or her duties?

12.8

What qualifications are required for this person?

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13.0 Projection Equipment Controls
13.1

Are one or more readily accessible controls provided to immediately terminate laser radiation?

»
13.2

*

Number of controls:

Describe the location of these controls and their operation relative to your show.

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Test and Notification Procedures
14.0 Test Procedures
14.1

Attach a copy of the written setup, alignment, and test procedures to be followed prior to the
operation of the laser light show at each location. If setup procedures are not a seperate form,
provide a detailed description below of procedures that are followed. Click on the Add... button
below to attach any supporting files.

14.2

When are these setup, alignment, and test procedures performed?

14.3

What laser radiation levels are used during setup, alignment, and checkout? (in milliwatts)

14.4

Is a written record of the results of the setup, alignment, and test procedures maintained?

»

Explain how adequate quality assurance is maintained:

»

You may attach records such as Standard Operating Procedures (SOPs), Quality Safety Checklists,
and Daily Logs.

*

Details
Note:

Adequate recordkeeping would include, but not limited to: (1) sketches showing the location
of the laser projector(s), operator(s), performer(s), audience, beam paths, viewing screens,
wall mirrors, mirror balls, and other surfaces that may be struck by the laser beams; (2)
information on scanning patterns, velocity, and frequency; and/or (3) laser radiation levels
used in each effect.

15.0 Notification Procedures
15.1

What procedures are followed for notification of appropriate Federal (CDRH, FAA), State and
local agencies? Either attach a file, form letters, or describe procedures in the text box below.
Click on the Add... button to attach any supporting files.

*

What Federal, State and local agencies are notified or would be notified?
Item
Stop:

No Information Provided.
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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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