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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 K222081
Device Name ID-510 iRestore Elite
Applicant
Freedom Laser Therapy, Inc.
16782 Von Karman Ave., Unit 15
Irvine,  CA  92606
Applicant Contact Wei-Chih Chen
Correspondent
Emergo Global Consulting, LLC
2500 Bee Cave Rd., Bldg. 1 Suite 300
Austin,  TX  78746
Correspondent Contact Sharon Chen
Regulation Number890.5500
Classification Product Code
OAP  
Date Received07/15/2022
Decision Date 10/13/2022
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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