Cleared Traditional

308nm Excimer System (K172273) - FDA 510(k) Clearance

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

K172273 · Chongqing Peninsula Medical Technology Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2018
Decision
367d
Days
Class 2
Risk

K172273 is an FDA 510(k) clearance for the 308nm Excimer System. Classified as Light, Ultraviolet, Dermatological (product code FTC), Class II - Special Controls.

Submitted by Chongqing Peninsula Medical Technology Co., Ltd. (Chongqing, CN). The FDA issued a Cleared decision on July 30, 2018 after a review of 367 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Chongqing Peninsula Medical Technology Co., Ltd. devices

Submission Details

510(k) Number K172273 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 2017
Decision Date July 30, 2018
Days to Decision 367 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
252d slower than avg
Panel avg: 115d · This submission: 367d
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

Guangzhou GLOMED Biological Technology Co., Ltd.
Cassie Lee

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 K172273.
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
UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD, SQ308PCNFD, SQ308PCMFD)
K242908 · Shanghai Sigma High-Tech Co., Ltd. · Dec 2024