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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 K181253
Device Name Bosley Revitalizer 272 Laser Cap, Bosley Revitalizer 164 Laser Cup
PJM Worldwide, LLC d/b/a Phoenix Medical Technology, LLC
1499 NW 79th Avenue
Miami,  FL  33126
Applicant Contact Ira Nusbaum
Grace Consulting, LLC
6615 Lake Shore Drive, Ste 806
Minneapolis,  MN  55423
Correspondent Contact Ronald Berglund
Regulation Number890.5500
Classification Product Code
Date Received05/11/2018
Decision Date 08/10/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No