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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 K183671
Device Name LG PRA.L DERMA LED MASK
Applicant
Lg Electronics.Inc
222, Lg-Ro, Jinwi-Myeon
Pyeongtaek-Si,  KR 17709
Applicant Contact Jooyong Kim
Correspondent
Bt Solutions, Inc.
904, Eonju-Ro 86-Gil 5,
Seoul,  KR 06210
Correspondent Contact Do-Hyun Kim
Regulation Number878.4810
Classification Product Code
OHS  
Date Received12/27/2018
Decision Date 01/22/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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