Cleared Special

Capillus 112, Capillus 244 (K192012) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K192012 · Capillus · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2019
Decision
45d
Days
Class 2
Risk

K192012 is an FDA 510(k) clearance for the Capillus 112, Capillus 244. Classified as Laser, Comb, Hair (product code OAP), Class II - Special Controls.

Submitted by Capillus (Miami, US). The FDA issued a Cleared decision on September 12, 2019 after a review of 45 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.

View all Capillus devices

Submission Details

510(k) Number K192012 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2019
Decision Date September 12, 2019
Days to Decision 45 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
70d faster than avg
Panel avg: 115d · This submission: 45d
Pathway characteristics
Modification to existing cleared device.

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.

Regulatory Peers - OAP Laser, Comb, Hair

All 107
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