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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Over-The-Counter Powered Light Based Laser For Acne
510(k) Number K162371
Device Name Pulsaderm ACE-All Blue
Applicant
Nutra Luxe MD, LLC
12801 Commonwealth Dr. Unit 5
Fort Meyers,  FL  33913
Applicant Contact Gloria Avendano
Correspondent
Nutra Luxe MD, LLC
12801 Commonwealth Dr. Unit 5
Fort Meyers,  FL  33913
Correspondent Contact Gloria Avendano
Regulation Number878.4810
Classification Product Code
OLP  
Date Received08/24/2016
Decision Date 12/15/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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