Cleared Traditional

K242908 - UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD, SQ308PCNFD, SQ308PCMFD) (FDA 510(k) Clearance)

Also includes:
UV Phototherapy Device (Group B: SQ308PHTFF, SQ308PHSFF, SQ308PHRFF, SQ308PHZFG, SQ308PPUFF, SQ308PPVFF, SQ308PPWFG)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K242908 · Shanghai Sigma High-Tech Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2024
Decision
86d
Days
Class 2
Risk

K242908 is an FDA 510(k) clearance for the UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD, SQ308PCN.... Classified as Light, Ultraviolet, Dermatological (product code FTC), Class II - Special Controls.

Submitted by Shanghai Sigma High-Tech Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on December 19, 2024 after a review of 86 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4630 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Shanghai Sigma High-Tech Co., Ltd. devices

Submission Details

510(k) Number K242908 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2024
Decision Date December 19, 2024
Days to Decision 86 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 114d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FTC Light, Ultraviolet, Dermatological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4630
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Consultant

Microkn Medical Technology Service (Shanghai) Co., Ltd.
He Owen

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FTC Light, Ultraviolet, Dermatological

All 271
Devices cleared under the same product code (FTC) and FDA review panel - the closest regulatory comparables to K242908.
Phototherapy System (DUV-COMBO)
K254234 · Choyang Medics Co., Ltd. · May 2026
Klär Lite (RCW-KL1000)
K253871 · Radcliffe Watts, LLC · Mar 2026
Ultraviolet Phototherapy Device
K250425 · APK Technology Co., Ltd. · Apr 2025
308nm UV Phototherapy System (UV-K)
K244022 · Boston Aesthetics, Inc. · Mar 2025
308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K)
K242977 · Xuzhou Kernel Medical Equipment Co., Ltd. · Feb 2025
DT Controlled Phototherapy Equipment
K233811 · Daavlin Distributing Co. · Dec 2023