Cleared Traditional

K143199 - Capillus 272 Pro

K143199 is an FDA 510(k) clearance for Capillus 272 Pro, manufactured by Capillus, LLC. The device is a Class 2 General & Plastic Surgery device with product code OAP cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K143199 · Capillus, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2015
Decision
84d
Days
Class 2
Risk

K143199 is an FDA 510(k) clearance for the Capillus 272 Pro. Classified as Laser, Comb, Hair (product code OAP), Class II - Special Controls.

Submitted by Capillus, LLC (Coral Gables, US). The FDA issued a Cleared decision on January 29, 2015 after a review of 84 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.

FDA 510(k) Submission Details - K143199

510(k) Number K143199 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 2014
Decision Date January 29, 2015
Days to Decision 84 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
31d faster than avg
Panel avg: 115d · This submission: 84d
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
NCT01967277 Completed Interventional Industry-sponsored

A Novel Approach to Treating Androgenetic Alopecia in Females With Low Level Laser Therapy

44
Patients (actual)
2
Sites
Treatment
Purpose
Quadruple
Masking
Condition studied Androgenetic Alopecia
Study design Parallel
Eligibility Female only · 18 Years+ · Healthy volunteers accepted
Principal investigator Raymond R. Blanche, BA
Sponsor Capillus, LLC (industry)
Started 2014-03-01 → Primary completion 2014-08-01 → Completed 2014-09-01
Primary outcome
Percentage Increase in Terminal Hair Counts From Pre-Treatment, Baseline for Active Test Subjects Over the Placebo Test Subjects.
View full study on ClinicalTrials.gov

Regulatory Peers - OAP Laser, Comb, Hair

All 113
Devices cleared under the same product code (OAP) and FDA review panel - the closest regulatory comparables to K143199.
LaserCap LC Pro and LC Elite
K150613 · Transdermal Cap, Inc. · Jul 2015
Capillus 272 Office Pro
K150578 · Capillus, LLC · Jun 2015
LX-100 Hair Growth Stimulation System
K142824 · Hairlabs International, Inc. · Apr 2015
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