SculpSure
FDA 510(k) clearance K182741 · decided 2019-01-03
Clearance details
- K-number
- K182741
- Device name
- SculpSure
- Applicant
- Cynosure
- Decision
- Substantially Equivalent
- Date received
- 2018-09-28
- Decision date
- 2019-01-03
- Days to decision
- 97 days
- Clearance type
- Traditional
- Product code
- PKT
- Device class
- 2
- Regulation number
- 878.5400
- 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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Recalls involving this device
No recalls on record reference this clearance.