Cleared Traditional

Hair Growth System

K190685 · Xuzhou Kernel Medical Equipment Co., Ltd. · General & Plastic Surgery

Jul 2019

Decision

130d

Days

Class 2

Risk

About This 510(k) Submission

K190685 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 July 26, 2019, 130 days after receiving the submission on March 18, 2019. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 890.5500.

Submission Details

510(k) Number	K190685 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 18, 2019
Decision Date	July 26, 2019
Days to Decision	130 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