Cleared Special

K192585 - Bosley Revitalizer 96 Laser Cap, Bosley Revitalizer 96 XL Laser Cap

K192585 is an FDA 510(k) clearance for Bosley Revitalizer 96 Laser Cap, manufactured by Pjm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC. The device is a Class 2 General & Plastic Surgery device with product code OAP cleared through the Special 510(k) pathway after a 132-day FDA review.

K192585 · Pjm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K192585

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.

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 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 115
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K192585 · Bosley Revitalizer 96 Laser Cap, Bosley Revitalizer 96 XL Laser Cap
Download PDF FDA Summary Pjm Worldwide, LLC D/…