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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 K201107
Device Name Opera Lebody (Gold), Opera Lebody (Zafiro)
Applicant
Gtg Wellness Co., Ltd.
767, Sinsu-Ro, Suju-Gu
Yongin-Si,  KR 16827
Applicant Contact Sang Won Jun
Correspondent
Mdr Solutions Co., Ltd.
1435 Kanchanapisek Rd. Bang Khae Nuea, Bang Khae
Bangkok,  TH 10160
Correspondent Contact Paweena U-Thainual
Regulation Number878.4810
Classification Product Code
OHS  
Date Received04/24/2020
Decision Date 06/22/2020
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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