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U.S. Department of Health and Human Services

Class 2 Device Recall Pure Rayz, Light Therapy System

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 Class 2 Device Recall Pure Rayz, Light Therapy Systemsee related information
Date Initiated by FirmJune 29, 2018
Create DateSeptember 05, 2018
Recall Status1 Terminated 3 on August 27, 2019
Recall NumberZ-2973-2018
Recall Event ID 80496
510(K)NumberK130225 
Product Classification Light based over the counter wrinkle reduction - Product Code OHS
ProductBaby Quasar Plus, Light Therapy System, packaging, box, sleeve and user manual. Handheld Wrinkles Reduction Device.
Code Information Product Number DPA-023. UPC Code 0 91037 46144 5
FEI Number 3006182559
Recalling Firm/
Manufacturer		 Quasar Bio-Tech, Inc.
1465 Tallevast Rd
Sarasota FL 34243-5036
For Additional Information Contact
800-944-1523
Manufacturer 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.
FDA Determined
Cause 2		Under Investigation by firm
ActionQuasar 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 Commerce6,783 units total
DistributionNationwide distribution to CA, FL, GA, HI, IL, LA, MD, NE, NY, OH, TX, VA, WA, WI. Worldwide distribution to Australia, China, Netherlands, United Kingdom
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = OHS
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