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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 K132838
Device Name NUTRA LIGHT BLUE
Applicant
Nutra Luxe MD, LLC
5575 Santa Rosa Ct.
Sparks,  NV  89436
Applicant Contact JILL CREASY
Correspondent
Nutra Luxe MD, LLC
5575 Santa Rosa Ct.
Sparks,  NV  89436
Correspondent Contact JILL CREASY
Regulation Number878.4810
Classification Product Code
OLP  
Date Received09/10/2013
Decision Date 05/23/2014
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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