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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 K183417
Device Name iRestore Professional 282
Applicant
Freedom Laser Therapy, Inc.
16782 Von Karman Ave., Unit 15
Irvine,  CA  92606
Applicant Contact Craig Nabat
Correspondent
Nst Consultants, Inc.
641 Shunpike Rd.
Suite 311
Chatham,  NJ  07928
Correspondent Contact Raymond R. Blanche
Regulation Number890.5500
Classification Product Code
OAP  
Date Received12/10/2018
Decision Date 05/17/2019
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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