Z-2975-2018Class II

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

Name: Z-2975-2018 Pure Rayz, Light Therapy System, packaging, box, sleeve and user manual. Handheld Wrinkles Reduction Device
Creator: Quasar Bio-Tech, Inc.
Published: 2018-06-29
License: https://open.fda.gov/license/

Quasar Bio-Tech Inc / initiated 2018-06-29 / Terminated / root cause: packaging

FDA source

Quasar Bio-Tech, Inc. began a recall of Pure Rayz, Light Therapy System, packaging, box, sleeve and user manual. Handheld Wrinkles Reduction Device on 2018-06-29. FDA classified it as Class II and gives the reason as "Quasar did not receive FDA clearance for claims of collagen/elastin production as stated on the packaging and in the user manuals". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2975-2018
Classification: Class II
Status: Terminated
Initiated: 2018-06-29
Posted: 2018-09-05
Terminated: 2019-08-27
Recalling firm: Quasar Bio-Tech Inc
Product: Pure Rayz, Light Therapy System, packaging, box, sleeve and user manual. Handheld Wrinkles Reduction Device.
Product code: OHS Light Based Over The Counter Wrinkle Reduction
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.
Root cause tag: packaging
FDA root cause: Under Investigation by firm
Action: Quasar Bio-Tech notified customers on about 06/20/2018 via URGENT PRODUCT RECALL letter. Instructions included place any current, affected inventory on hold and arrange for return to Quasar Bio-Tech, Inc. Customers were also instructed to complete and return the reply form. Questions or concerns should be directed to Quasar Bio-Tech, Inc., at 800-944-1523 or 941-306-5812.
Quantity in commerce: 6,783 units total
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
Product codes and lots: Product Number DPA-026. UPC Code 0 91037 46140 7

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2975-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2973-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-12	2018-09-05
Z-2974-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-12	2018-09-05
Z-2975-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-12	2018-09-05

Product code OHS

K130225Class IIQuasar C100, Baby Quasar Plus, Quasar Md Plus; Wrinkle Reduction DeviceSilverbay, LLC, D/B/A Quasar Bio-Tech / cleared 2013-07-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)