Cleared Traditional

K190467 - iHelmet Hair Growth System

K190467 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 303-day FDA review.

K190467 · Slinph Technologies Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
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Dec 2019
Decision
303d
Days
Class 2
Risk

K190467 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 December 26, 2019 after a review of 303 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K190467

510(k) Number K190467 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 2019
Decision Date December 26, 2019
Days to Decision 303 days
Submission Type Traditional
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
188d slower than avg
Panel avg: 115d · This submission: 303d
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 Consultant

Sk Medical Device International Corp.
S K

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - OAP Laser, Comb, Hair

All 108
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