UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD, SQ308PCNFD, SQ308PCMFD) +1 more— 510(k) K242908

Name: FDA 510(k) clearance K242908
Creator: U.S. Food and Drug Administration
Published: 2024-12-19

Substantially Equivalent

Shanghai Sigma High-Tech Co., Ltd.

FDA 510(k) clearance K242908 for UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD, SQ308PCNFD, SQ308PCMFD) +1 more, Substantially Equivalent on 2024-12-19. Applicant: Shanghai Sigma High-Tech Co., Ltd.. Device class: 2.

Clearance details

Device name as filed: UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD, SQ308PCNFD, SQ308PCMFD); UV Phototherapy Device (Group B: SQ308PHTFF, SQ308PHSFF, SQ308PHRFF, SQ308PHZFG, SQ308PPUFF, SQ308PPVFF, SQ308PPWFG)
Applicant: Shanghai Sigma High-Tech Co., Ltd.
Product code: Code FTC
Device class: Class 2
Regulation: 21 CFR 878.4630
Advisory panel: General, Plastic Surgery
Date received: 2024-09-24
Decision date: 2024-12-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code FTC

view all

K254234 — Phototherapy System (DUV-COMBO)2026-05-01
K253871 — Klär Lite (RCW-KL1000)2026-03-04
K250425 — Ultraviolet Phototherapy Device2025-04-07
K244022 — 308nm UV Phototherapy System (4 models)2025-03-13
K242977 — 308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K)2025-02-06

Data sourced from openFDA. This site is unofficial and independent of the FDA.