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Laser Light Show Annual Report

Created From "Guide For Preparing Annual Reports..." 21 CFR 1002.7
Revised September 1995

From

Should be the name of your company or your name if there is no company involved. This field tells the FDA who registered the variance holder is, whether that is a company or an individual.
Full mailing address including city, state and zip. (business address if for a company, personal address for an individual)
The phone number you provide should be the best possible phone number used to reach you.
Date*
The date to input is today’s date.
//

To CDRH,

Please accept this annual report to fulfill reporting requirements under Title 21 of the Code of Federal Regulations (CFR), Parts 1002 and 1003 which specify Reporting and Notification requirements.

Please address any questions or correspondence to the above.

Created exclusively for users of X-Laser LLC's Class IIIB and IV laser light show products

X-Laser LLC

9115 Whiskey Bottom Road

Suite H

Laurel, MD 20723

https://x-laser.com

301-543-1981

variances@x-laser.com

 

Part 1. Identification of Manufacturer (Variance Holder)

Report Date:*
The date to input is today’s date
//
Should be the same as the “Name” field from page 1, regardless of whether you are a company or not
Should be your business address.
Should be your business city.
Should be your business state.
Should be your business zip code.
Role within your company.

This Annual Report is submitted in accordance with 21 CFR 1002.13 for the period of:

July 1, (previous year)

through

June 30, (current year)

Part 2. Production Status

Please remember that your laser light show is considered a "product" and you are considered a "manufacturer." As long as you are still in business and using your lasers, please leave the "check mark" in the top option selected as is. ONLY SELECT ONE

Part 3. Current Production Tabulation

3.1 All Laser Products

Can be found on page 1 of your variance under section A. Format 20xx-V-xxxx.
A model family consists of more than one model essentially identical in application, design, and performance.
Enter the model name(s) of the X-Laser product(s) you are using. For example, if you own a Mobile Beat Mirage, just write that. If you also use high-powered laser products not made by X-Laser, you need to report them in a separate attachment with your annual report and write “See Attached”. For such products, you need to include model numbers/names, where the products were manufactured and by whom, etc. Contact the other manufacturer(s) to obtain their FDA reporting details.
Indicate the primary application of each model, e.g.,cutting; trimming; welding; surgery; alignment; surveying.
Give the laser product class of each model listed.
Model Number - Active/Inactive
Provide discontinuation date (month and year) for any model that is no longer in production but was produced at some time during the reporting period.
Codes may be used for each plant location if you provide the codes and complete address for each manufacturing location on a separate sheet, labeled Part 3.

3.2 Laser Light Shows

Can be found on page 1 of your variance near the top in the Remarks. Format xxAxxxx sometimes RHxxAxxxx.
A model family consists of more than one model essentially identical in application, design, and performance.
Indicate type of use environment. For multiple performances at a fixed location, such as at a planetarium, indicate (permanent). For one or more performances at multiple locations, indicate (touring).  An answer of "both" is acceptable too if that applies to your shows.
Give the laser product class of each model listed.
Write in the number of times that you used your laser in the past “laser show year” i.e. July 1 through June 30. An approximate number is acceptable here.
Provide discontinuation date (month and year) for any model that is no longer in production but was produced at some time during the reporting period.

Part 4. Procedures for Quality Control and Testing

The written procedures for assessing and controlling radiation safety have been reviewed. (These include prototype testing, incoming materials testing, assembly testing, retesting after repair, and service testing.) The procedures for maintaining quality control testing equipment have also been reviewed. All procedures are up-to-date, complete, and accurate.*
The reports provided to CDRH for each model family currently in production have been reviewed and the procedures contained in them are up-to-date, complete, and accurate.*
Upload supplement here if required

Part 5. Summary of Test Results

Write whatever your laser show is called. If you don’t have a specific name for your laser show, it’s OK to make up one. For example, if your nightclub is called “Poker,” you could input “Poker’s Laser Show”.
Write in the number of times that you used your laser in the past “laser show year” i.e. July 1 through June 30. An approximate number is acceptable here.  Should be the same answer as Section 3.2 - Number of Shows Performed.

Part 6. Correspondence Concerning Radiation Safety

Part 7. Distribution Records

Products can be traced from these records by