Cleared Traditional

Laser Hair Growth System (Laser Cap 128, Laser Helmet 272, Laser Helmet 352, Laser Helmet 552, Laser Helmet 500) (K253231) - FDA 510(k) Clearance

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

K253231 · Hubei Yjt Technology Co.,Ltd · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2026
Decision
260d
Days
Class 2
Risk

K253231 is an FDA 510(k) clearance for the Laser Hair Growth System (Laser Cap 128, Laser Helmet 272, Laser Helmet 352, .... 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 June 16, 2026 after a review of 260 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 Hubei Yjt Technology Co.,Ltd devices

Submission Details

510(k) Number K253231 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2025
Decision Date June 16, 2026
Days to Decision 260 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
145d slower than avg
Panel avg: 115d · This submission: 260d
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 Peers - OAP Laser, Comb, Hair

All 72
Devices cleared under the same product code (OAP) and FDA review panel - the closest regulatory comparables to K253231.
Alma TED+ System
K251684 · Alma Lasers, Inc. · Jun 2026
TRUDERMAL HALO HAIR GROWTH SYSTEM (M-180A)
K253669 · Shenzhen Kaiyan Medical Equipment Co., Ltd. · Jan 2026
Hair Regrowth Cap (Model: T-119-HRC)
K253349 · Light Tree Ventures Europe B.V. · Dec 2025
Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1)
K252414 · Shenzhen Kaiyan Medical Equipment Co., Ltd. · Oct 2025
Hair Growth Laser Cap
K252325 · Cosmo Far East Technology Limited · Oct 2025
CurrentBody Skin Dual Light Hair Growth Helmet (model: MZ-07A)
K251017 · Shenzhen Kaiyan Medical Equipment Co., Ltd. · Jun 2025