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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 K151662
FOIA Releasable 510(k) K151662
Device Name iRestore
Applicant
Freedom Laser Therapy, Inc.
7815 Beverly Blvd., 3rd Floor
Los Angeles,  CA  90036
Applicant Contact Craig Nabat
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 Received06/19/2015
Decision Date 01/06/2016
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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