Cleared Traditional

CurrentBody Skin Dual Light Hair Growth Helmet (model: MZ-07A)

K251017 · Shenzhen Kaiyan Medical Equipment Co., Ltd. · General & Plastic Surgery

Jun 2025

Decision

76d

Days

Class 2

Risk

About This 510(k) Submission

K251017 is an FDA 510(k) clearance for the CurrentBody Skin Dual Light Hair Growth Helmet (model: MZ-07A), a Laser, Comb, Hair (Class II — Special Controls, product code OAP), submitted by Shenzhen Kaiyan Medical Equipment Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on June 17, 2025, 76 days after receiving the submission on April 2, 2025. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 890.5500.

Submission Details

510(k) Number	K251017 FDA.gov
FDA Decision	Cleared 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

Device Classification

Product Code	OAP — Laser, Comb, Hair
Device Class	Class II — 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