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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name laser, comb, hair
510(k) Number K200464
Device Name LG Pra. L Derma LD Scalp Care
LG Electronics, Inc.
222 LG-ro Jinwi-myeon
Pyeongtaek-si,  KR 17709
Applicant Contact Eunmi Ji
BT Solutions, Inc.
904-ho, Eonju-ro 86-gil 5 Gangnam-gu
Seoul,  KR 06210
Correspondent Contact Do-Hyun Kim
Regulation Number890.5500
Classification Product Code
Date Received02/26/2020
Decision Date 07/23/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No