Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
K192585Substantially Equivalent

Bosley Revitalizer 96 Laser Cap, Bosley Revitalizer 96 XL Laser Cap

Pjm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC, Miami FL / Special, Substantially Equivalent

K192585 is the FDA 510(k) clearance record for Bosley Revitalizer 96 Laser Cap, Bosley Revitalizer 96 XL Laser Cap, a class II device, cleared for Pjm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC on under FDA product code OAP (Laser, Comb, Hair). FDA's definition for product code OAP reads: "Promote hair growth in males with androgenic alopecia and norwood hamilton classification of iia to v". FDA records list 2 510(k) clearances for Pjm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC, from to . As of , FDA records show no recalls naming K192585.

Clearance record

Decision date
Received
(132 days to decision)
Product code
OAP Laser, Comb, Hair
Regulation
21 CFR 890.5500
Device class
Class II
Review panel
Physical Medicine
Applicant
Pjm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC 1499 NW 79th Ave., Miami FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OAP

Trailing 12 months
9 clearances under product code OAP in the twelve months to October 2026, June 2026 the highest month at 4.
Show the numbers
Monthly 510(k) clearances under FDA product code OAP, trailing twelve months
MonthClearances
November 20250
December 20251
January 20261
February 20260
March 20260
April 20260
May 20260
June 20264
July 20261
August 20260
September 20262
October 20260