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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 K143199
Device Name Capillus 272 Pro
Applicant
Capillus, LLC
1430 S. Dixie Highway, Suite 304
Coral Gables,  FL  33146
Applicant Contact Frances Pina Brea
Correspondent
Capillus, LLC
1430 S. Dixie Hwy
Suite 304
Coral Gables,  FL  33146
Correspondent Contact Patricia Schnoor
Regulation Number890.5500
Classification Product Code
OAP  
Date Received11/06/2014
Decision Date 01/29/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Clinical Trials NCT01967277
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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