K244022 is an FDA 510(k) clearance for the 308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV Phototherapy System (UV-Y); 308nm UV Phototherapy System (UV-Z), a Light, Ultraviolet, Dermatological (Class II — Special Controls, product code FTC), submitted by Boston Aesthetics, Inc. (Wilmington, US). The FDA issued a Cleared decision on March 13, 2025, 76 days after receiving the submission on December 27, 2024. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4630.
| 510(k) Number | K244022 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 27, 2024 |
| Decision Date | March 13, 2025 |
| Days to Decision | 76 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FTC — Light, Ultraviolet, Dermatological |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.4630 |