K244022
- 510(k) number
- K244022
- Device name
- 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. DE · US
- Product code
- FTC — Light, Ultraviolet, Dermatological
- Decision date
- 2025-03-13
- Date received
- 2024-12-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K244022.pdf
Official FDA record: K244022
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.