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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 K150613
Device Name LaserCap LC Pro and LC Elite
Applicant
Transdermal Cap, Inc.
3615 Superior Ave., Suite 3104f
Cleveland,  OH  44114
Applicant Contact MICHAEL RABIN
Correspondent
Nst Consulting, LLC
641 Shunpike Rd.
Suite 311
Chatham,  NJ  07928
Correspondent Contact RAYMOND R. BLANCHE
Regulation Number890.5500
Classification Product Code
OAP  
Date Received03/10/2015
Decision Date 07/22/2015
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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