Cleared Special

K192425 - Hair Boom 69

K192425 is the FDA 510(k) clearance for Hair Boom 69 by Wontech Co., Ltd.. It is a Class 2 General & Plastic Surgery device (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)
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.

View all Wontech Co., Ltd. devices

Submission Details

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.

Device Classification

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 71
Devices cleared under the same product code (OAP) and FDA review panel - the closest regulatory comparables to K192425.
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K191154 · Wontech · Jul 2019
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