Cleared Traditional

K252414 - Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1)

K252414 is an FDA 510(k) clearance for Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1), manufactured by Shenzhen Kaiyan Medical Equipment 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 90-day FDA review.

K252414 · Shenzhen Kaiyan Medical Equipment Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2025
Decision
90d
Days
Class 2
Risk

K252414 is an FDA 510(k) clearance for the Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1). Classified as Laser, Comb, Hair (product code OAP), Class II - Special Controls.

Submitted by Shenzhen Kaiyan Medical Equipment Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on October 30, 2025 after a review of 90 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 Shenzhen Kaiyan Medical Equipment Co., Ltd. devices

FDA 510(k) Submission Details - K252414

510(k) Number K252414 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2025
Decision Date October 30, 2025
Days to Decision 90 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
25d faster than avg
Panel avg: 115d · This submission: 90d
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 Peers - OAP Laser, Comb, Hair

All 108
Devices cleared under the same product code (OAP) and FDA review panel - the closest regulatory comparables to K252414.
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
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
Red Light Hair Growth Cap (LP-RJVGRW-BLK)
K250467 · Shenzhen Idea Light Limited · Jun 2025