Quasar Bio-Tech Inc
Yorba Linda, CA, US
Quasar Bio-Tech Inc appears in FDA device records in Yorba Linda, CA. FDA records list no 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show 6 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Quasar Bio-Tech Inc carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Quasar Bio-Tech, Inc. dba Silver Bay LLCenforcement report, recall
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3006182559 | 3006182559 | Quasar Bio-Tech Inc | 4588 PONDEROSA WAY, Yorba Linda, CA 92886 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2975-2018 | Pure Rayz, Light Therapy System, packaging, box, sleeve and user manual. Handheld Wrinkles Reduction Device. | Quasar did not receive FDA clearance for claims of collagen/elastin production as stated on the packaging and in the user manuals. | Class II | Terminated | |
| Z-2974-2018 | Quasar MD Plus, Light Therapy System, packaging, box, sleeve and user manual. Handheld Wrinkles Reduction Device. | Quasar did not receive FDA clearance for claims of collagen/elastin production as stated on the packaging and in the user manuals. | Class II | Terminated | |
| Z-2973-2018 | Baby Quasar Plus, Light Therapy System, packaging, box, sleeve and user manual. Handheld Wrinkles Reduction Device. | Quasar did not receive FDA clearance for claims of collagen/elastin production as stated on the packaging and in the user manuals. | Class II | Terminated | |
| Z-0519-2013 | 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 POWERPACK***FOR YOUTHFUL, RADIANT, CLEAR SKIN***SKIN REJUVENATING SYSTEM WITH SEQUEPULSE PLUS ADVANCED ACNE CLARIFYING SYSTEM***Manufactured by: Quasar Biotech, Inc., BPP101 LAB-003-E, ***Made in the USA with highest quality components and durable aluminum. Five Year Warranty.***" | Quasar Bio-Tech is recalling their Baby Quasar, Baby Quasar Pink, Quasar Power Pack, and Quasar MD because the device is unapproved. | Class II | Terminated | |
| Z-0518-2013 | Quasar MD is an infrared LED lamp that is labeled in part: "***QUASAR MD***Bringing the Spa Home***Radiant and Youthful Skin***QUASAR MD INCLUDES***QUASAR MD***USER MANUAL***12 VOLT POWER SUPPLY***1 OZ PURE SILK SERUM***Made in the USA.***Five year warranty***" The product emits energy in the near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature. This device may be used to provide temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm. This device may temporarily increase local blood circulation, and may be used to promote relaxation of the muscle tissue. | Quasar Bio-Tech is recalling their Baby Quasar, Baby Quasar Pink, Quasar Power Pack, and Quasar MD because the device is unapproved. | Class II | Terminated | |
| Z-0517-2013 | Baby Quasar (LAB-001-D, BQ101) and Baby Quasar Pink (LAB-046-A BQ101-P) are infrared LED lamps that are labeled in part: "***BABY QUASAR***FOR YOUTHFUL RADIANT SKIN***Skin Rejuvenating System with Sequepulse***Manufactured by: Silver Bay, LLC; Made in the USA, with highest quality components and durable aluminum. Five Year Warranty The product emits energy in the near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature. This device may be used to provide temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm. This device may temporarily increase local blood circulation, and may be used to promote relaxation of the muscle tissue. | Quasar Bio-Tech is recalling their Baby Quasar, Baby Quasar Pink, Quasar Power Pack, and Quasar MD because the device is unapproved. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain