Cleared Special

Bosley Revitalizer 96 Laser Cap, Bosley Revitalizer 96 XL Laser Cap (K192585) - FDA 510(k) Clearance

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

K192585 · Pjm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2020
Decision
132d
Days
Class 2
Risk

K192585 is an FDA 510(k) clearance for the Bosley Revitalizer 96 Laser Cap, Bosley Revitalizer 96 XL Laser Cap. Classified as Laser, Comb, Hair (product code OAP), Class II - Special Controls.

Submitted by Pjm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC (Miami, US). The FDA issued a Cleared decision on January 29, 2020 after a review of 132 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. 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Pjm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC devices

Submission Details

510(k) Number K192585 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 2019
Decision Date January 29, 2020
Days to Decision 132 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
17d slower than avg
Panel avg: 115d · This submission: 132d
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 Consultant

Grace Consulting, LLC
Ronald Berglund

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - OAP Laser, Comb, Hair

All 107
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