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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 K160728
Device Name NutraStim Hair Laser Helmet
Applicant
Nutra Luxe MD, LLC
12801 Commonwealth Dr. Unit 2-6
Fort Myers,  FL  33976
Applicant Contact GLORIA AVENDANO
Correspondent
Nutra Luxe MD, LLC
12801 Commonwealth Dr. Unit 2-6
Fort Myers,  FL  33976
Correspondent Contact GLORIA AVENDANO
Regulation Number890.5500
Classification Product Code
OAP  
Date Received03/16/2016
Decision Date 09/16/2016
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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