Cleared Traditional

K162782 - iHelmet Hair Growth System

K162782 is an FDA 510(k) clearance for iHelmet Hair Growth System, manufactured by Slinph Technologies 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 183-day FDA review.

K162782 · Slinph Technologies Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2017
Decision
183d
Days
Class 2
Risk

K162782 is an FDA 510(k) clearance for the iHelmet Hair Growth System. Classified as Laser, Comb, Hair (product code OAP), Class II - Special Controls.

Submitted by Slinph Technologies Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on April 4, 2017 after a review of 183 days - an extended review 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. 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 Slinph Technologies Co., Ltd. devices

FDA 510(k) Submission Details - K162782

510(k) Number K162782 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 2016
Decision Date April 04, 2017
Days to Decision 183 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d slower than avg
Panel avg: 115d · This submission: 183d
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 K162782.
Hair Up
K172968 · Y & J Bio Co., Ltd. · Jan 2018
SuperGrow 272, Ultimate 272
K172982 · Super Grow Lasers · Dec 2017
Grivamax Hair Growth System
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IllumiFlow Laser Cap
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Capillus 82, Capillus 202, Capillus 272 Pro, 272 Office Pro, Capillus 302, Capillus 312, and Capillus 352
K163170 · Capillus, LLC · Jan 2017
Capillus302, Capillus312, Capillus352
K162994 · Capillus, LLC · Nov 2016