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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 K180847
Device Name Neutrogena Light Therapy Acne Mask+
Applicant
Johnson & Johnson Consumer, Inc.
7050 Camp Hill Rd.
Fort Washington,  PA  19034
Applicant Contact Timothy Kline
Correspondent
Johnson & Johnson Consumer, Inc.
7050 Camp Hill Rd.
Fort Washington,  PA  19034
Correspondent Contact Timothy Kline
Regulation Number878.4810
Classification Product Code
OLP  
Date Received04/02/2018
Decision Date 06/19/2018
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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