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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 K213094
Device Name ID-500 iRestore Hair Growth System
Freedom Laser Therapy, Inc.
16782 Von Karman Avenue, Unit 15
Irvine,  CA  92606
Applicant Contact Wei-Chih (Kevin) Chen
Emergo Global Consulting, LLC
2500 Bee Cave Road, Building 1, Suite 300
Austin,  TX  78746
Correspondent Contact Sharon Chen
Regulation Number890.5500
Classification Product Code
Date Received09/24/2021
Decision Date 12/22/2021
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