Cleared Traditional

Irradiation Cosmetic Device (K192552) - FDA 510(k) Clearance

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

K192552 · Chongqing Peninsula Medical Technology Co., Ltd. · General & Plastic Surgery device
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Apr 2020
Decision
213d
Days
Class 2
Risk

K192552 is an FDA 510(k) clearance for the Irradiation Cosmetic Device. Classified as Laser, Comb, Hair (product code OAP), Class II - Special Controls.

Submitted by Chongqing Peninsula Medical Technology Co., Ltd. (Jiulongpo District, CN). The FDA issued a Cleared decision on April 17, 2020 after a review of 213 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 890.5500 - 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 Chongqing Peninsula Medical Technology Co., Ltd. devices

Submission Details

510(k) Number K192552 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 2019
Decision Date April 17, 2020
Days to Decision 213 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
98d slower than avg
Panel avg: 115d · This submission: 213d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OAP Laser, Comb, Hair
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5500
Definition Promote Hair Growth In Males With Androgenic Alopecia And Norwood Hamilton Classification Of Iia To V
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 - OAP Laser, Comb, Hair

All 107
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