Cleared Traditional

K253669 - TRUDERMAL HALO HAIR GROWTH SYSTEM (M-180A)

Also marketed or referenced as:
ADURO HAIR GROWTH (M-130,M-300)

K253669 is an FDA 510(k) clearance for TRUDERMAL HALO HAIR GROWTH SYSTEM (M-180A), 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 63-day FDA review.

K253669 · Shenzhen Kaiyan Medical Equipment Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2026
Decision
63d
Days
Class 2
Risk

K253669 is an FDA 510(k) clearance for the TRUDERMAL HALO HAIR GROWTH SYSTEM (M-180A). 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 January 23, 2026 after a review of 63 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Shenzhen Kaiyan Medical Equipment Co., Ltd. devices

FDA 510(k) Submission Details - K253669

510(k) Number K253669 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2025
Decision Date January 23, 2026
Days to Decision 63 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
52d faster than avg
Panel avg: 115d · This submission: 63d
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 K253669.
Laser Hair Growth System (Laser Cap 128, Laser Helmet 272, Laser Helmet 352, Laser Helmet 552, Laser Helmet 500)
K253231 · Hubei Yjt Technology Co.,Ltd · Jun 2026
Laser Hair Growth Device (F21151, F21152, F21153, F21154, F21155, F21156, F21157, F21158, F21159)
K260899 · Zdeer Technology (Henan) Co., Ltd. · Jun 2026
Alma TED+ System
K251684 · Alma Lasers, Inc. · Jun 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