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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 K153618
FOIA Releasable 510(k) K153618
Device Name Capillus202
Applicant
CAPILLUS, LLC
1715 NW 82nd AVE
MIAMI,  FL  33126
Applicant Contact PATRICIA SCHNOOR
Correspondent
CAPILLUS, LLC
1715 NW 82nd AVE
MIAMI,  FL  33126
Correspondent Contact PATRICIA SCHNOOR
Regulation Number890.5500
Classification Product Code
OAP  
Date Received12/18/2015
Decision Date 01/19/2016
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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