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
- 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
Recent devices under product code FTC
view all- K254234 — Phototherapy System (DUV-COMBO)
- K253871 — Klär Lite (RCW-KL1000)
- K250425 — Ultraviolet Phototherapy Device
- K242977 — 308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K)
- K242908 — UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD, SQ308PCNFD, SQ308PCMFD) +1 more
More clearances from Boston Aesthetics, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.