TempSure System— 510(k) K200241
Substantially EquivalentCynosure, LLC
FDA 510(k) clearance K200241 for TempSure System, Substantially Equivalent on 2020-03-25. Applicant: Cynosure, LLC. Device class: 2.
Clearance details
- Applicant
- Cynosure, LLC
- Product code
- Code PBX
- Device class
- Class 2
- Regulation
- 21 CFR 878.4400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wesford, MA, US
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