308nm UV Phototherapy System (4 models)— 510(k) K244022
Substantially EquivalentBoston Aesthetics, Inc.
FDA 510(k) clearance K244022 for 308nm UV Phototherapy System (4 models), Substantially Equivalent on 2025-03-13. Applicant: Boston Aesthetics, Inc.. Device class: 2.
Clearance details
- Device name as filed
- 308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV Phototherapy System (UV-Y); 308nm UV Phototherapy System (UV-Z)
- Applicant
- Boston Aesthetics, Inc.
- Product code
- Product code FTC
- Device class
- Class 2
- Regulation
- 21 CFR 878.4630
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wilmington, DE, US
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