Cleared Traditional

K111714 - HAIRMAX DUAL 12

K111714 is an FDA 510(k) clearance for HAIRMAX DUAL 12, 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 57-day FDA review.

K111714 · Lexington International, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2011
Decision
57d
Days
Class 2
Risk

K111714 is an FDA 510(k) clearance for the HAIRMAX DUAL 12. 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 August 16, 2011 after a review of 57 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 - K111714

510(k) Number K111714 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 2011
Decision Date August 16, 2011
Days to Decision 57 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
58d faster than avg
Panel avg: 115d · This submission: 57d
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 K111714.
IGROW II HAIR GROWTH SYSTEM
K122248 · Apira Science, Inc. · Dec 2012
LASER HELMET
K113097 · Theradome, Inc. · Mar 2012
HAIRMAX LASERCOMB
K112524 · Lexington International, LLC · Sep 2011
HAIRMAX LASERCOMB
K110233 · Lexington International, LLC · May 2011
HAIRMAX LASERCOMB
K103368 · Lexington International, LLC · Apr 2011