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Get Fda Variance 2020-2024

REASON FOR REQUESTING VARIANCE Compliance with the limits of 21 CFR 1040. 11 c would restrict the intended use of the product because compliance would limit the output power to the extent that the desired effects would not be sufficiently visible Other or additional explanation Specify FORM FDA 3147 8/17 PREVIOUS EDITION IS OBSOLETE PSC Publishing Services 301 443-6740 EF PAGE 1 OF 4 PAGES 11. DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration APPLICATION FOR A VARIANCE FROM 21 CFR 1040. 11 c FOR A LASER LIGHT SHOW DISPLAY OR DEVICE Form Approved OMB No* 0910-0025 Expiration Date July 31 2020 See Page 4 for PRA Statement. DOCKET NUMBER NOTE No laser light show projection system or device may vary from compliance with 21 CFR 1040. 11 c in design or use without the approval of this application in accordance with 21 CFR 1010. 4. INSTRUCTIONS 1. Check all applicable boxes and type or print the requested information* 2. Submit an original and four 4 copies. 3. Mail your application to the Division of Dockets Management HFA-305 Food and Drug Administration Rm 1061 5630 Fishers Lane Rockville MD 20852. 4. Enter docket number if assigned* 1. NAME OF COMPANY 2. ADDRESS OF COMPANY Include ZIP Code If P. O. Box is used include actual street address also. 3. NAME AND TITLE OF RESPONSIBLE PERSON 4. a* TELEPHONE NO. Include area code 4. b. EMAIL ADDRESS 5. DATE OF SUBMISSION 6. THE APPLICANT REQUESTS THE VARIANCE TO BE IN EFFECT FOR A PERIOD OF YEARS FROM THE DATE OF ISSUE* In general the Agency will approve a variance for only two years. If a longer period is requested a justification must be attached as part of the application* PRODUCT DESCRIPTION AND USE a* LIST NAME AND/OR MODEL NUMBER S FOR THE LASER LIGHT SHOW S AND PROJECTOR S b. PRODUCT FOR WHICH A VARIANCE IS REQUESTED A laser display device A projector for a laser light show A laser light show Other Specify c* PROJECTORS ARE INTENDED FOR SALE LEASE OR LOAN TO OTHER LASER LIGHT SHOW PRODUCERS d. PRODUCT IS INTENDED FOR USE IN A Planetarium or other dome projection structure Theater Hotel/motel ballroom or meeting room Store displays Trade show or convention Discotheque or night club Pavilion Indoor arena Outdoor arena Museum Outdoor unenclosed area More than 15 days More than 5 but not more than 15 days Less than 5 days g. TOUR IS INTENDED TO RUN FOR More than 6 months 1 - 6 months Less than one month Not applicable Not a tour h. PRODUCT UTILIZES THE FOLLOWING LASER EFFECTS Front screen projections Rear screen projections Holographic displays Multiple reflection/diffraction effects Audience scanning Also includes scanning any accessible uncontrolled areas Reflections from stationary mirrors or mirrored surfaces Beam Matrices At only one Fixed location At a variety of Tour locations Stationary irradiation of rotating mirror balls etc* Scanning irradiation of rotating mirror balls etc* Fiber optic projections Fog smoke or other scattering enhancement effects LASER RADIATION LEVELS LASER MEDIUM Ar He-Ne etc* WAVE LENGTHS nm PEAK POWER watts 9.

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