Cleared Traditional

K262183 - Hair Growth Helmet (TK-176, TK-600, TK-500, TK-282, TK-500A, TK-282A, TK-126, TK-60)

K262183 is an FDA 510(k) clearance for Hair Growth Helmet (TK-176, manufactured by Shenzhen Nuon 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 87-day FDA review.

K262183 · Shenzhen Nuon Medical Equipment Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2026
Decision
87d
Days
Class 2
Risk

K262183 is an FDA 510(k) clearance for the Hair Growth Helmet (TK-176, TK-600, TK-500, TK-282, TK-500A, TK-282A, TK-126,.... Classified as Laser, Comb, Hair (product code OAP), Class II - Special Controls.

Submitted by Shenzhen Nuon Medical Equipment Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on September 24, 2026 after a review of 87 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 Nuon Medical Equipment Co., Ltd. devices

FDA 510(k) Submission Details - K262183

510(k) Number K262183 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 2026
Decision Date September 24, 2026
Days to Decision 87 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
28d faster than avg
Panel avg: 115d · This submission: 87d
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 113
Devices cleared under the same product code (OAP) and FDA review panel - the closest regulatory comparables to K262183.
Hair Growth Comb (X-GC01)
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Alma TED+ System
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