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U.S. Department of Health and Human Services

Product Classification

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Device high-power laser light show projector
Definition Product, laser, demo, projector, laser light show/display, class iiib/iv/3b/4; Laser projection system that incorporates a laser having a maximum radiation output power greater than 5mw.
Product CodeREA
Device Class Not Classified
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? Yes
    Note: This device is also exempted from the GMP regulation, except for general requirements concerning records (820.180) and complaint files (820.198), as long as the device is not labeled or otherwise represented as sterile.
Summary Malfunction
Reporting
Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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