Sculpsure— 510(k) K171111
Substantially EquivalentCynosure, Inc.
FDA 510(k) clearance K171111 for Sculpsure, Substantially Equivalent on 2017-06-13. Applicant: Cynosure, Inc.. Device class: 2.
Clearance details
- Applicant
- Cynosure, Inc.
- Product code
- Code PKT
- Device class
- Class 2
- Regulation
- 21 CFR 878.5400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Westford, MA, US
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