Cleared Special

K182501 - Hair Laser Headband

K182501 is the FDA 510(k) clearance for Hair Laser Headband by Pulsaderm, LLC. It is a Class 2 General & Plastic Surgery device (product code OAP) cleared through the Special 510(k) pathway after a 44-day FDA review.

K182501 · Pulsaderm, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2018
Decision
44d
Days
Class 2
Risk

K182501 is an FDA 510(k) clearance for the Hair Laser Headband. Classified as Laser, Comb, Hair (product code OAP), Class II - Special Controls.

Submitted by Pulsaderm, LLC (Fort Myers, US). The FDA issued a Cleared decision on October 26, 2018 after a review of 44 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 Pulsaderm, LLC devices

Submission Details

510(k) Number K182501 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 2018
Decision Date October 26, 2018
Days to Decision 44 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
71d faster than avg
Panel avg: 115d · This submission: 44d
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 71
Devices cleared under the same product code (OAP) and FDA review panel - the closest regulatory comparables to K182501.
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K181253 · Pjm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC · Aug 2018