Device product
Quasar MD Plus, Light Therapy System, packaging, box, sleeve and user manual. Handheld Wrinkles Reduction Device.
Z-2974-2018
Product summary
- Event
- Event 80496
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6,783 units total
- Official record key
device-enforcement:Z-2974-2018
Official wording
Reason: Quasar did not receive FDA clearance for claims of collagen/elastin production as stated on the packaging and in the user manuals.
Code information: Product Number DPA-024. UPC Code 0 91037 46143 8
Distribution pattern: Nationwide distribution to CA, FL, GA, HI, IL, LA, MD, NE, NY, OH, TX, VA, WA, WI. Worldwide distribution to Australia, China, Netherlands, United Kingdom
Derived failure modes
-
Unknown
Quasar did not receive FDA clearance for claims of collagen/elastin production as stated on the packaging and in the user manuals.