Cleared Special

K162994 - Capillus302, Capillus312, Capillus352

K162994 is an FDA 510(k) clearance for Capillus302, manufactured by Capillus, LLC. The device is a Class 2 General & Plastic Surgery device with product code OAP cleared through the Special 510(k) pathway after a 22-day FDA review.

K162994 · Capillus, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2016
Decision
22d
Days
Class 2
Risk

K162994 is an FDA 510(k) clearance for the Capillus302, Capillus312, Capillus352. Classified as Laser, Comb, Hair (product code OAP), Class II - Special Controls.

Submitted by Capillus, LLC (Miami, US). The FDA issued a Cleared decision on November 18, 2016 after a review of 22 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K162994

510(k) Number K162994 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 2016
Decision Date November 18, 2016
Days to Decision 22 days
Submission Type Special
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
93d faster than avg
Panel avg: 115d · This submission: 22d
Pathway characteristics
Modification to existing cleared device.

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 113
Devices cleared under the same product code (OAP) and FDA review panel - the closest regulatory comparables to K162994.
iHelmet Hair Growth System
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Capillus 82, Capillus 202, Capillus 272 Pro, 272 Office Pro, Capillus 302, Capillus 312, and Capillus 352
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NutraStim Hair Laser Helmet
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K161046 · Theradome, Inc. · May 2016