Cleared Traditional

K191754 - Hair Growth System

K191754 is an FDA 510(k) clearance for Hair Growth System, manufactured by Kunshan Bella Optical Technology 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 144-day FDA review.

K191754 · Kunshan Bella Optical Technology Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2019
Decision
144d
Days
Class 2
Risk

K191754 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 Kunshan Bella Optical Technology Co., Ltd. (Kunshan, CN). The FDA issued a Cleared decision on November 22, 2019 after a review of 144 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 Kunshan Bella Optical Technology Co., Ltd. devices

FDA 510(k) Submission Details - K191754

510(k) Number K191754 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2019
Decision Date November 22, 2019
Days to Decision 144 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d slower than avg
Panel avg: 115d · This submission: 144d
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 Peers - OAP Laser, Comb, Hair

All 108
Devices cleared under the same product code (OAP) and FDA review panel - the closest regulatory comparables to K191754.
Bosley Revitalizer 96 Laser Cap, Bosley Revitalizer 96 XL Laser Cap
K192585 · Pjm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC · Jan 2020
iHelmet Hair Growth System
K190467 · Slinph Technologies Co., Ltd. · Dec 2019
Laser Hair Growth Cap
K192627 · Shang FA Biotechnology Co. · Dec 2019
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