• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall GaGa Pro Laser Light Show (LLS) projector systems

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall GaGa Pro Laser Light Show (LLS) projector systemssee related information
Date Initiated by FirmSeptember 23, 2022
Date PostedMarch 29, 2023
Recall Status1 Open3, Classified
Recall NumberZ-1290-2023
Recall Event ID 91969
Product Classification High-power laser light show projector - Product Code REA
ProductGaGa Pro Lighting Equipment Co. Ltd. manufactures Class IV Laser Light Show (LLS)projectors for the purposes of demonstration and entertainment.
Code Information GA-RGB3000, GA-A4-W10000, GA-ML500-8, GA-RGB8000, GA-RGB4000, GA-RGB5000, GA-G4000M, and GA-ML1800
FEI Number 3013936259
Recalling Firm/
Manufacturer
GAGA PRO LIGHTING EQUIPMENT CO.,
1238 Longjiao Road
Industrial Area
Guangzhou China
For Additional Information ContactChristopher M Utter
443-953-1788
Manufacturer Reason
for Recall
GAGA Pro LLS systems was not in compliance with the FDA's Performance Standard for laser products.
FDA Determined
Cause 2
Radiation Control for Health and Safety Act
ActionGaGa. will send a Customer Notification letter to the affected customers by certified mail. The letter will identify the affected product, problem and actions to be taken. GAGA lighting will offer free upgrades to update your GAGA Laser projector to the current FDA requirements. Alternatively, you may choose to ship your laser projector to GAGA Lighting s U.S. agent, Laser Display Company, in order to get it fixed. GAGA Lighting will pay for shipping costs. GAGA Lighting, without charge, will bring the product into compliance with each applicable Federal standard for laser products.
Quantity in Commerce11 units
DistributionUS Nationwide Distribution
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
-
-