BABY QUASAR
FDA 510(k) clearance K091467 · decided 2010-09-17
Clearance details
- K-number
- K091467
- Device name
- BABY QUASAR
- Applicant
- Silver Bay, LLC
- Decision
- Substantially Equivalent
- Date received
- 2009-05-18
- Decision date
- 2010-09-17
- Days to decision
- 487 days
- Clearance type
- Traditional
- Product code
- ONE
- Device class
- 2
- Regulation number
- 878.4810
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Deerfield, IL, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
| handLITE (TN19S) (K250224) | iSMART Developments, Ltd. | 2025-04-18 |
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| PLASMALUXLS (K100628) | Daavlin Distributing Co. | 2010-11-24 |
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| ANTI-WRINKLE (AGING) LIGHT, MODEL AAL (K092800) | Led Intellectual Properties, LLC | 2010-02-04 |
Recalls involving this device
No recalls on record reference this clearance.