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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laser, Comb, Hair
510(k) Number K192585
Device Name Bosley Revitalizer 96 Laser Cap, Bosley Revitalizer 96 XL Laser Cap
Applicant
Pjm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC
1499 NW 79th Ave.
Miami,  FL  33126
Applicant Contact Ira Nusbaum
Correspondent
Grace Consulting, LLC
6615 Lake Shore Dr., Suite 605
Minneapolis,  MN  55423
Correspondent Contact Ronald Berglund
Regulation Number890.5500
Classification Product Code
OAP  
Date Received09/19/2019
Decision Date 01/29/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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