FDA-Device2018-09-12Class II

Quasar MD Plus, Light Therapy System, packaging, box, sleeve and user manual. Handheld Wrinkles Reduction Device.

Quasar Bio-Tech, Inc.
Hazard

Quasar did not receive FDA clearance for claims of collagen/elastin production as stated on the packaging and in the user manuals.

Sold states
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
Affected count
6,783 units total
Manufactured in
1465 Tallevast Rd, N/A, Sarasota, FL, United States
Products
Quasar MD Plus, Light Therapy System, packaging, box, sleeve and user manual. Handheld Wrinkles Reduction Device.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2974-2018

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