Cleared Traditional

K110233 - HAIRMAX LASERCOMB

K110233 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 121-day FDA review.

K110233 · Lexington International, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2011
Decision
121d
Days
Class 2
Risk

K110233 is an FDA 510(k) clearance for the HAIRMAX LASERCOMB. Classified as Laser, Comb, Hair (product code OAP), Class II - Special Controls.

Submitted by Lexington International, LLC (Washington, US). The FDA issued a Cleared decision on May 27, 2011 after a review of 121 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 Lexington International, LLC devices

FDA 510(k) Submission Details - K110233

510(k) Number K110233 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 2011
Decision Date May 27, 2011
Days to Decision 121 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
6d slower than avg
Panel avg: 115d · This submission: 121d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most General & Plastic Surgery devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT00981461 Completed Interventional Industry-sponsored

Treatment of Androgenetic Alopecia in Females, 9 Beam

A Randomized, Double-Blind Clinical Trial to Evaluate the Safety and Efficacy of the HairMax LaserComb 2009, 9 Beam Model: For the Treatment of Androgenetic Alopecia in Females

72
Patients (actual)
5
Sites
Treatment
Purpose
Quadruple
Masking
Condition studied Androgenetic Alopecia; Hair Loss; Female Pattern Baldness
Study design Parallel
Eligibility Female only · 25 Years+ · Healthy volunteers accepted
Principal investigator Michael Jarratt, M.D.
Sponsor Lexington International, LLC (industry)
Started 2009-10-01 → Primary completion 2010-10-01
Primary outcome
Changes in Terminal Hair Count Week 16 and 26 Weeks Over Baseline
View full study on ClinicalTrials.gov