Cleared Traditional

K230134 - Laser Therapy Hair Growth Comb

K230134 is an FDA 510(k) clearance for Laser Therapy Hair Growth Comb, manufactured by Hubei Yjt Technology Co.,Ltd. The device is a Class 2 General & Plastic Surgery device with product code OAP cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K230134 · Hubei Yjt Technology Co.,Ltd · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2023
Decision
126d
Days
Class 2
Risk

K230134 is an FDA 510(k) clearance for the Laser Therapy Hair Growth Comb, Model: Lasercomb-001 & Lasercomb-002. Classified as Laser, Comb, Hair (product code OAP), Class II - Special Controls.

Submitted by Hubei Yjt Technology Co.,Ltd (Wuhan, CN). The FDA issued a Cleared decision on May 23, 2023 after a review of 126 days - within the typical 510(k) review window.

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 Hubei Yjt Technology Co.,Ltd devices

FDA 510(k) Submission Details - K230134

510(k) Number K230134 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 2023
Decision Date May 23, 2023
Days to Decision 126 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
11d slower than avg
Panel avg: 115d · This submission: 126d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OAP Device Classification - Class 2, Special Controls

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

Tacro Guangzhou Branch
Gamma Zhang

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 K230134.
Nooance Led And Laser Helmet
K231321 · Shenzhen Kaiyan Medical Equipment Co., Ltd. · Jul 2023
Neuhat Hair Growth System
K231153 · Nature, Inc.redible, Inc. · Jun 2023
F65 Laser System
K222790 · Lumenis Be, Ltd. · Jun 2023
Hair Boom 69, Hair BoomAir, Hair Boom, Ulike Hair UpUp
K223862 · Wontech Co., Ltd. · Apr 2023
Aduro Comb (Model: SZ-22, SZ-22A, SZ-22B)
K230597 · Light Tree Ventures Europe B.V. · Apr 2023
CurrentBody Skin™ Led Hair Regrowth(Model: MZ-07)
K230336 · Light Tree Ventures Europe B.V. · Apr 2023