FDA recall Z-2975-2018

Product

Pure Rayz, Light Therapy System, packaging, box, sleeve and user manual. Handheld Wrinkles Reduction Device.

Reason for recall

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

Distribution

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

Key facts

Status

Terminated

Initiation date

2018-06-29

Report date

2018-09-12

Termination date

2019-08-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Sarasota, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2975-2018