Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2975-2018·Announced 2018-09-12

Quasar Pure Rayz Light Therapy System Recalled for Uncleared 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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text explicitly states that the issue is a lack of clearance for specific claims rather than a physical defect or contamination. Since no injuries or illnesses are reported and the hazard is regulatory/labeling-related, it fits the Moderate category for minor labeling or documentation issues.

Plain-English summary

Quasar Bio-Tech, Inc. is recalling 6,783 units of the Pure Rayz Light Therapy System, a handheld wrinkles reduction device. The recall involves the product packaging, box, sleeve, and user manual. The devices were distributed nationwide to California, Florida, Georgia, Hawaii, Illinois, Louisiana, Maryland, Nebraska, New York, Ohio, Texas, Virginia, Washington, and Wisconsin, as well as internationally to Australia, China, the Netherlands, and the United Kingdom.

The recall was initiated because Quasar did not receive FDA clearance for the claims of collagen and elastin production stated on the packaging and in the user manuals. The source text does not report any illnesses, injuries, or deaths associated with the use of the device.

Consumers who purchased the Pure Rayz Light Therapy System should stop using the product and contact Quasar Bio-Tech, Inc. for instructions on how to return the device or obtain a refund. The product is identified by Product Number DPA-026 and UPC Code 0 91037 46140 7.

The recalled product

Product: Pure Rayz, Light Therapy System, packaging, box, sleeve and user manual. Handheld Wrinkles Reduction Device.
Manufacturer: Quasar Bio-Tech, Inc.
Category: Medical Device — Light Therapy
Hazard: mis-labeling
uncleared-claims
Affected units: 6,783

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

Product Number DPA-026. UPC Code 0 91037 46140 7

Distribution

Distributed nationwide across the United States.

The notice also names 14 states specifically:

Part of a larger recall action

This product is one of 3 recalled by Quasar Bio-Tech, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Same manufacturer · Quasar Bio-Tech, Inc.

See all →

Moderate
Quasar MD Plus Light Therapy System Recalled for Uncleared Claims
FDA (Devices) · 2018-09-12
Moderate
Quasar Bio-Tech Recalls Baby Quasar Plus Light Therapy System
FDA (Devices) · 2018-09-12

Same hazard · mis labeling