Cleared Traditional

K172273 - 308nm Excimer System

K172273 is the FDA 510(k) clearance for 308nm Excimer System by Chongqing Peninsula Medical Technology Co., Ltd.. It is a Class 2 General & Plastic Surgery device (product code FTC) cleared through the Traditional 510(k) pathway after a 367-day FDA review.

K172273 · Chongqing Peninsula Medical Technology Co., Ltd. · General & Plastic Surgery device
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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

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