Cleared Traditional

K180885 - HairMax Laser

K180885 is the FDA 510(k) clearance for HairMax Laser by Lexington International, LLC. It is a Class 2 General & Plastic Surgery device (product code OAP) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K180885 · Lexington International, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2018
Decision
77d
Days
Class 2
Risk

K180885 is an FDA 510(k) clearance for the HairMax Laser. Classified as Laser, Comb, Hair (product code OAP), Class II - Special Controls.

Submitted by Lexington International, LLC (Boca Raton, US). The FDA issued a Cleared decision on June 20, 2018 after a review of 77 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Lexington International, LLC devices

Submission Details

510(k) Number K180885 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2018
Decision Date June 20, 2018
Days to Decision 77 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
38d faster than avg
Panel avg: 115d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Consultant

Nst Consulting, LLC
Raymond R Blanche

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 71
Devices cleared under the same product code (OAP) and FDA review panel - the closest regulatory comparables to K180885.
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