Device product
GaGa Pro Lighting Equipment Co. Ltd. manufactures Class IV Laser Light Show (LLS)projectors for the purposes of demonstration and entertainment.
Z-1290-2023
Product summary
- Event
- Event 91969
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 11 units
- Official record key
device-enforcement:Z-1290-2023
Official wording
Reason: GAGA Pro LLS systems was not in compliance with the FDA's Performance Standard for laser products.
Code information: GA-RGB3000, GA-A4-W10000, GA-ML500-8, GA-RGB8000, GA-RGB4000, GA-RGB5000, GA-G4000M, and GA-ML1800
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Unknown
GAGA Pro LLS systems was not in compliance with the FDA's Performance Standard for laser products.