Cleared Traditional

Laser Hair Growth Comb (K213027) - FDA 510(k) Clearance

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

K213027 · Kam Yuen Plastic Products , Ltd. · General & Plastic Surgery device
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May 2022
Decision
247d
Days
Class 2
Risk

K213027 is an FDA 510(k) clearance for the Laser Hair Growth Comb. Classified as Laser, Comb, Hair (product code OAP), Class II - Special Controls.

Submitted by Kam Yuen Plastic Products , Ltd. (Zhongshan, CN). The FDA issued a Cleared decision on May 26, 2022 after a review of 247 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 Kam Yuen Plastic Products , Ltd. devices

Submission Details

510(k) Number K213027 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 2021
Decision Date May 26, 2022
Days to Decision 247 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
132d slower than avg
Panel avg: 115d · This submission: 247d
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

Guangdong Jianda Medical Technology Co., Ltd.
Jett 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 71
Devices cleared under the same product code (OAP) and FDA review panel - the closest regulatory comparables to K213027.
Xtrallux Alpha (XA136R-USA), Xtrallux Super Plus (XS276R-USA/XS276L-USA), Xtrallux Turbo Pro (XP316R-USA), Xtrallux Extreme RX (XR352R-USA)
K222364 · Xtrallux, LLC · Nov 2022
ID-510 iRestore Elite
K222081 · Freedom Laser Therapy, Inc. · Oct 2022
Intelligence LaserComb
K213789 · Yibin Yingtong Intelligent Technology Co., Ltd. · Jun 2022
Laser hair growth helmet
K213025 · Kam Yuen Plastic Products , Ltd. · May 2022
Auxo A300, A150 and APod
K220543 · Auxo Hair, LLC · Apr 2022
LLLT Laser Hair Growth Cap, Model: Hair Care 88, Hair Care 135, Hair Care 210.
K213447 · Shenzhen Cosbeauty Technology Co., Ltd. · Jan 2022