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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light Based Over The Counter Wrinkle Reduction
510(k) Number K170984
Device Name LG BEAUTY LED MASK
Applicant
Lg Electronics
222, Lg-Ro, Jinwi-Myeon
Pyeongtaek-Si,  KR 17709
Applicant Contact Jooyong Kim
Correspondent
Bt Solutions, Inc.
Unit 502
148 Yuksamro
Seoul,  KR 06249
Correspondent Contact Minusk Kim
Regulation Number878.4810
Classification Product Code
OHS  
Subsequent Product Code
OLP  
Date Received04/03/2017
Decision Date 08/23/2017
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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