Cleared Traditional

K251017 - CurrentBody Skin Dual Light Hair Growth Helmet (model: MZ-07A) (FDA 510(k) Clearance)

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

K251017 · Shenzhen Kaiyan Medical Equipment Co., Ltd. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Jun 2025
Decision
76d
Days
Class 2
Risk

K251017 is an FDA 510(k) clearance for the CurrentBody Skin Dual Light Hair Growth Helmet (model: MZ-07A). 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 June 17, 2025 after a review of 76 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

Submission Details

510(k) Number K251017 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 2025
Decision Date June 17, 2025
Days to Decision 76 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
38d faster than avg
Panel avg: 114d · This submission: 76d
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 106
Devices cleared under the same product code (OAP) and FDA review panel - the closest regulatory comparables to K251017.
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
Red Light Hair Growth Cap (LP-RJVGRW-BLK)
K250467 · Shenzhen Idea Light Limited · Jun 2025
Hair Growth Device (KCA441-200, KCA441-120, KCA441-88, KCA441-56, KCA441-200S, KCA441-120S, KCA441-88S, KCA441-56S, KCA451-200, KCA451-120, KCA451-88, KCA451-56, KCA451-200S, KCA451-120S, KCA451-88S, KCA451-56S)
K250308 · Dongguan Boyuan Intelligent Technology Co.,Ltd · Apr 2025