Cleared Traditional

K060305 - HAIRMAX LASERCOMB

K060305 is the FDA 510(k) clearance for HAIRMAX LASERCOMB 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 346-day FDA review.

K060305 · Lexington International, LLC · General & Plastic Surgery device
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Jan 2007
Decision
346d
Days
Class 2
Risk

K060305 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 January 18, 2007 after a review of 346 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.

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Submission Details

510(k) Number K060305 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 2006
Decision Date January 18, 2007
Days to Decision 346 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
231d slower than avg
Panel avg: 115d · This submission: 346d
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.