Cleared Traditional

K190685 - Hair Growth System

K190685 is an FDA 510(k) clearance for Hair Growth System, manufactured by Xuzhou Kernel 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 130-day FDA review.

K190685 · Xuzhou Kernel Medical Equipment Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2019
Decision
130d
Days
Class 2
Risk

K190685 is an FDA 510(k) clearance for the Hair Growth System. Classified as Laser, Comb, Hair (product code OAP), Class II - Special Controls.

Submitted by Xuzhou Kernel Medical Equipment Co., Ltd. (Suzhou, CN). The FDA issued a Cleared decision on July 26, 2019 after a review of 130 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Xuzhou Kernel Medical Equipment Co., Ltd. devices

FDA 510(k) Submission Details - K190685

510(k) Number K190685 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d slower than avg
Panel avg: 115d · This submission: 130d
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 Consultant

Guangzhou Keda Biological Tech Co., Ltd.
Jet Li

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - OAP Laser, Comb, Hair

All 71
Devices cleared under the same product code (OAP) and FDA review panel - the closest regulatory comparables to K190685.
Hair Boom 69, Hair Boom Air, Ulike Hair UpUp
K192425 · Wontech Co., Ltd. · Sep 2019
Capillus 112, Capillus 244
K192012 · Capillus · Sep 2019
Hair Boom 69
K191154 · Wontech · Jul 2019
iRestore Professional 282
K183417 · Freedom Laser Therapy, Inc. · May 2019
Laser Hair Therapy
K183329 · Omm Imports, Inc. D/B/A Zero Gravity · Jan 2019
Hair Boom 69
K182562 · Wontech · Nov 2018