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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 K161941
Device Name Pulsaderm Acne Device
Applicant
Nutra Luxe MD, LLC
12801 Commonwealth Dr.
Unit 2-6
Fort Myers,  FL  33913
Applicant Contact GLORIA AVENDANO
Correspondent
Nutra Luxe MD, LLC
12801 Commonwealth Dr.
Unit 2-6
Fort Myers,  FL  33913
Correspondent Contact GLORIA AVENDANO
Regulation Number878.4810
Classification Product Code
OLP  
Date Received07/15/2016
Decision Date 10/19/2016
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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