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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 K163170
Device Name Capillus 82, Capillus 202, Capillus 272 Pro, 272 Office Pro, Capillus 302, Capillus 312, and Capillus 352
Applicant
CAPILLUS, LLC
1715 NW 82nd Avenue
MIAMI,  FL  33126
Applicant Contact PATRICIA SCHNOOR
Correspondent
CAPILLUS, LLC
1715 NW 82nd Avenue
MIAMI,  FL  33126
Correspondent Contact PATRICIA SCHNOOR
Regulation Number890.5500
Classification Product Code
OAP  
Date Received11/14/2016
Decision Date 01/31/2017
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
Predetermined Change
Control Plan Authorized		 No
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