Cleared Special

K223862 - Hair Boom 69, Hair BoomAir, Hair Boom, Ulike Hair UpUp

K223862 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 126-day FDA review.

K223862 · 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
Apr 2023
Decision
126d
Days
Class 2
Risk

K223862 is an FDA 510(k) clearance for the Hair Boom 69, Hair BoomAir, Hair Boom, 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 April 28, 2023 after a review of 126 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. 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. Standard predicate reliance. 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 - K223862

510(k) Number K223862 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2022
Decision Date April 28, 2023
Days to Decision 126 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
11d slower than avg
Panel avg: 115d · This submission: 126d
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 K223862.
Neuhat Hair Growth System
K231153 · Nature, Inc.redible, Inc. · Jun 2023
F65 Laser System
K222790 · Lumenis Be, Ltd. · Jun 2023
Laser Therapy Hair Growth Comb, Model: Lasercomb-001 & Lasercomb-002
K230134 · Hubei Yjt Technology Co.,Ltd · May 2023
Aduro Comb (Model: SZ-22, SZ-22A, SZ-22B)
K230597 · Light Tree Ventures Europe B.V. · Apr 2023
CurrentBody Skin™ Led Hair Regrowth(Model: MZ-07)
K230336 · Light Tree Ventures Europe B.V. · Apr 2023
Hair Growth Device
K222477 · Dongguan Lescolton Medical Equipment Co., Ltd. · Nov 2022
K223862 · Hair Boom 69, Hair BoomAir, Hair Boom, Ulike Hair UpUp
Download PDF FDA Summary Wontech Co., Ltd.