Cleared Special

K192425 - Hair Boom 69, Hair Boom Air, Ulike Hair UpUp

K192425 is an FDA 510(k) clearance for Hair Boom 69, manufactured by Wontech Co., Ltd.. The device is a Class 2 General & Plastic Surgery device with product code OAP cleared through the Special 510(k) pathway after a 25-day FDA review.

K192425 · Wontech Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2019
Decision
25d
Days
Class 2
Risk

K192425 is an FDA 510(k) clearance for the Hair Boom 69, Hair Boom Air, Ulike Hair UpUp. Classified as Laser, Comb, Hair (product code OAP), Class II - Special Controls.

Submitted by Wontech Co., Ltd. (64, Techno 8-Ro, Yuseong-Gu, KR). The FDA issued a Cleared decision on September 30, 2019 after a review of 25 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K192425

510(k) Number K192425 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 2019
Decision Date September 30, 2019
Days to Decision 25 days
Submission Type Special
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
90d faster than avg
Panel avg: 115d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

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 Peers - OAP Laser, Comb, Hair

All 115
Devices cleared under the same product code (OAP) and FDA review panel - the closest regulatory comparables to K192425.
iHelmet Hair Growth System
K190467 · Slinph Technologies Co., Ltd. · Dec 2019
Laser Hair Growth Cap
K192627 · Shang FA Biotechnology Co. · Dec 2019
Hair Growth System
K191754 · Kunshan Bella Optical Technology Co., Ltd. · Nov 2019
Capillus 112, Capillus 244
K192012 · Capillus · Sep 2019
Hair Boom 69
K191154 · Wontech · Jul 2019
Hair Growth System
K190685 · Xuzhou Kernel Medical Equipment Co., Ltd. · Jul 2019
K192425 · Hair Boom 69, Hair Boom Air, Ulike Hair UpUp
Download PDF FDA Summary Wontech Co., Ltd.