Recall Z-2975-2018— Quasar Bio-Tech, Inc.

Name: FDA recall Z-2975-2018
Creator: U.S. Food and Drug Administration
Published: 2018-06-29

Class II · Terminated

Class II FDA medical device recall by Quasar Bio-Tech, Inc., initiated 2018-06-29, terminated 2019-08-27. It names one FDA 510(k) clearance: K130225. Product: Pure Rayz, Light Therapy System, packaging, box, sleeve and user manual. Handheld Wrinkles Reduction Device.. Reason: Quasar did not receive FDA clearance for claims of collagen/elastin production as stated on the packaging and in the user manuals..

Recalling firm: Quasar Bio-Tech, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-06-29
Terminated: 2019-08-27
Firm location: Sarasota, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K130225 — QUASAR C100, BABY QUASAR PLUS, QUASAR MD PLUS; WRINKLE REDUCTION DEVICESilverbay, LLC, D/B/A Quasar Bio-Tech·cleared 2013-07-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.