CELLULAZE LASER
FDA 510(k) clearance K123407 · decided 2013-03-29
Clearance details
- K-number
- K123407
- Device name
- CELLULAZE LASER
- Applicant
- Cynosure, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-11-05
- Decision date
- 2013-03-29
- Days to decision
- 144 days
- Clearance type
- Traditional
- Product code
- OYW
- Device class
- 2
- Regulation number
- 878.4810
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Wesford, MA, 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.
| Record | Firm | Date |
|---|---|---|
| CYNOSURE CELLULAZE LASER (K102541) | Cynosure, Inc. | 2012-01-26 |
Recalls involving this device
No recalls on record reference this clearance.