Cleared Traditional

K242977 - 308nm Excimer Phototherapy Device (CN-308E

K242977 is an FDA 510(k) clearance for 308nm Excimer Phototherapy Device (CN-308E, manufactured by Xuzhou Kernel Medical Equipment Co., Ltd.. The device is a Class 2 General & Plastic Surgery device with product code FTC cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K242977 · Xuzhou Kernel Medical Equipment Co., Ltd. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Feb 2025
Decision
133d
Days
Class 2
Risk

K242977 is an FDA 510(k) clearance for the 308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN.... Classified as Light, Ultraviolet, Dermatological (product code FTC), Class II - Special Controls.

Submitted by Xuzhou Kernel Medical Equipment Co., Ltd. (Xuzhou, CN). The FDA issued a Cleared decision on February 6, 2025 after a review of 133 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 Xuzhou Kernel Medical Equipment Co., Ltd. devices

FDA 510(k) Submission Details - K242977

510(k) Number K242977 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2024
Decision Date February 06, 2025
Days to Decision 133 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
18d slower than avg
Panel avg: 115d · This submission: 133d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FTC Device Classification - Class 2, Special Controls

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 Peers - FTC Light, Ultraviolet, Dermatological

All 51
Devices cleared under the same product code (FTC) and FDA review panel - the closest regulatory comparables to K242977.
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
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
Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02)
K223882 · Shenzhen Honpal Optoelectronic Technology Co., Ltd. · Mar 2023