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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
Freedom Laser Therapy, Inc.
16782 Von Karman Avenue, Unit #15
irvine,  CA  92606
Applicant Contact craig nabat
NST Consultants, Inc.
641 Shunpike Road, Suite 311
chatham,  NJ  07928
Correspondent Contact raymond r. blanche
Regulation Number890.5500
Classification Product Code
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