Cleared Traditional

Hair Growth System

K200929 · Xuzhou Kernel Medical Equipment Co., Ltd. · General & Plastic Surgery

Jun 2020

Decision

57d

Days

Class 2

Risk

About This 510(k) Submission

K200929 is an FDA 510(k) clearance for the Hair Growth System, a Laser, Comb, Hair (Class II — Special Controls, product code OAP), submitted by Xuzhou Kernel Medical Equipment Co., Ltd. (Suzhou, CN). The FDA issued a Cleared decision on June 3, 2020, 57 days after receiving the submission on April 7, 2020. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 890.5500.

Submission Details

510(k) Number	K200929 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 07, 2020
Decision Date	June 03, 2020
Days to Decision	57 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