Cleared Traditional

K142573 - HairMax LaserComb, HairMax LaserComb

K142573 is an FDA 510(k) clearance for HairMax LaserComb, manufactured by Lexington International, LLC. The device is a Class 2 General & Plastic Surgery device with product code OAP cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K142573 · Lexington International, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2014
Decision
80d
Days
Class 2
Risk

K142573 is an FDA 510(k) clearance for the HairMax LaserComb, HairMax LaserComb. 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 December 1, 2014 after a review of 80 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

FDA 510(k) Submission Details - K142573

510(k) Number K142573 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 2014
Decision Date December 01, 2014
Days to Decision 80 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
35d faster than avg
Panel avg: 115d · This submission: 80d
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

Olsson Frank Weeda Terman Matz PC
EVAN P PHELPS

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
Devices cleared under the same product code (OAP) and FDA review panel - the closest regulatory comparables to K142573.
NUTRA STIM HAIR LASER COMB
K141588 · Nutra Luxe MD, LLC · Jan 2015
NUTRA STIM HAIR LASER COMB
K141596 · Nutra Luxe MD, LLC · Jan 2015
IGROW II HAIR GROWTH SYSTEM
K140931 · Apira Science, Inc. · Dec 2014
IGROW - II HAIR GROWTH SYSTEM, IGROW HAIR GROWTH SYSTEM
K141567 · Apira Science, Inc. · Aug 2014
SUNETICS CLINICAL BIO-STIMULATION LASER
K132646 · Sunetics International Marketing Group, LLC · Dec 2013
LASERBRUSH
K121920 · Sunetics International Marketing Group, LLC · Jun 2013