Cleared Traditional

K254234 - Phototherapy System (DUV-COMBO) (FDA 510(k) Clearance)

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

K254234 · Choyang Medics Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2026
Decision
123d
Days
Class 2
Risk

K254234 is an FDA 510(k) clearance for the Phototherapy System (DUV-COMBO). Classified as Light, Ultraviolet, Dermatological (product code FTC), Class II - Special Controls.

Submitted by Choyang Medics Co., Ltd. (Seongnam-Si, KR). The FDA issued a Cleared decision on May 1, 2026 after a review of 123 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Choyang Medics Co., Ltd. devices

Submission Details

510(k) Number K254234 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 2025
Decision Date May 01, 2026
Days to Decision 123 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
9d slower than avg
Panel avg: 114d · This submission: 123d
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

SMB Korea Co.
Kim Kyung-Hwan

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 K254234.
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
UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD, SQ308PCNFD, SQ308PCMFD)
K242908 · Shanghai Sigma High-Tech Co., Ltd. · Dec 2024
DT Controlled Phototherapy Equipment
K233811 · Daavlin Distributing Co. · Dec 2023