FDA (Devices) recall action 80496
The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.
Quasar did not receive FDA clearance for claims of collagen/elastin production as stated on the packaging and in the user manuals.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Quasar Bio-Tech, Inc. is recalling the Quasar MD Plus Light Therapy System because the packaging and user manuals contain claims for collagen and elastin production that were not cleared by the FDA.
Quasar Bio-Tech is recalling the Baby Quasar Plus Light Therapy System because it lacks FDA clearance for specific collagen and elastin claims.
Quasar Bio-Tech is recalling 6,783 Pure Rayz Light Therapy Systems because the packaging and manuals make claims about collagen and elastin production that were not cleared by the FDA.