FDA Enforcement
Class II
Ongoing
GaGa Pro Lighting Equipment Co. Ltd. manufactures Class IV Laser Light Show (LLS)projectors for the purposes of demonstration and entertainment.
Recall: Z-1290-2023
·
Reported April 5, 2023
Enforcement
- Recall Number
- Z-1290-2023
- Event ID
- 91969
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- GAGA PRO LIGHTING EQUIPMENT CO.,
- Voluntary / Mandated
- FDA Mandated
- Initial Notification
- Letter
- Report Date
- April 5, 2023
- Initiation Date
- September 23, 2022
- Classification Date
- March 29, 2023
- Address
- 1238 Longjiao Road, Industrial Area, Guangzhou, N/A, N/A, China
Description
GaGa Pro Lighting Equipment Co. Ltd. manufactures Class IV Laser Light Show (LLS)projectors for the purposes of demonstration and entertainment.
Reason
GAGA Pro LLS systems was not in compliance with the FDA's Performance Standard for laser products.
Code Info
GA-RGB3000, GA-A4-W10000, GA-ML500-8, GA-RGB8000, GA-RGB4000, GA-RGB5000, GA-G4000M, and GA-ML1800
Distribution
US Nationwide Distribution
Quantity
11 units