Cleared Traditional

K150578 - Capillus 272 Office Pro

K150578 is an FDA 510(k) clearance for Capillus 272 Office 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 92-day FDA review.

K150578 · Capillus, LLC · General & Plastic Surgery device
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Jun 2015
Decision
92d
Days
Class 2
Risk

K150578 is an FDA 510(k) clearance for the Capillus 272 Office 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 June 9, 2015 after a review of 92 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 Capillus, LLC devices

FDA 510(k) Submission Details - K150578

510(k) Number K150578 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 2015
Decision Date June 09, 2015
Days to Decision 92 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
23d faster than avg
Panel avg: 115d · This submission: 92d
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.