QUASAR C100, BABY QUASAR PLUS, QUASAR MD PLUS; WRINKLE REDUCTION DEVICE
FDA 510(k) clearance K130225 · decided 2013-07-11
Clearance details
- K-number
- K130225
- Device name
- QUASAR C100, BABY QUASAR PLUS, QUASAR MD PLUS; WRINKLE REDUCTION DEVICE
- Applicant
- Silverbay, LLC, D/B/A Quasar Bio-Tech
- Decision
- Substantially Equivalent
- Date received
- 2013-01-29
- Decision date
- 2013-07-11
- Days to decision
- 163 days
- Clearance type
- Traditional
- Product code
- OHS
- Device class
- 2
- Regulation number
- 878.4810
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Coralville, IA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.