Quasar Bio-Tech Recalls Unapproved LED Skin Treatment Devices
Quasar Bio-Tech is recalling specific LED skin treatment devices because they are unapproved 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, and the source text does not report any illnesses, injuries, or deaths, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Quasar Bio-Tech, Inc. dba Silver Bay LLC is recalling the Baby Quasar, Baby Quasar Pink, Quasar Power Pack, and Quasar MD devices. The Quasar Power Pack includes the Baby Quasar and Baby Blue units, which use infrared and blue LED light to treat acne.
The recall is being conducted because the devices are unapproved. The affected units were distributed worldwide, including nationwide in the United States and in several international countries.
Consumers should stop using the affected devices. The recall number is Z-0519-2013.
The recalled product
- Product
- Quasar Power Pack contains a Baby Quasar and a Baby Blue. The Baby Quasar is an infrared LED lamp. The Baby Blue uses blue LED light to be used in combination with the Baby Quasar to treat acne. The Quasar Power Pack is labeled in part: "***BABY QUASAR & BABY BLUE***QUASAR…
- Manufacturer
- Quasar Bio-Tech, Inc. dba Silver Bay LLC
- Hazard
- Affected units
- 7,734
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 (19)
- Quasar Power Pack- Model BPP-101 UPC Code 837654050170
- Batch # 11253
- 11523
- 11658
- 2382
- 13009
- 13177
- 13186
- 13243
- 13270
- 13306
- 13327
- 13342
- 13459
- 13528
- 13529
- 13635
- 13730
- 13767.
Distribution
Part of a larger recall action
This product is one of 3 recalled by Quasar Bio-Tech, Inc. dba Silver Bay LLC 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 →Related recalls
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