Led Mask Platinum Md

Light Based Over The Counter Wrinkle Reduction

CellReturn Co., LTD.

The following data is part of a premarket notification filed by Cellreturn Co., Ltd. with the FDA for Led Mask Platinum Md.

Pre-market Notification Details

Device IDK222377
510k NumberK222377
Device Name:Led Mask Platinum Md
ClassificationLight Based Over The Counter Wrinkle Reduction
Applicant CellReturn Co., LTD. 237, Namdongseo-ro. Namdong-gu Incheon,  KR 21634
ContactIlsoo Kim
CorrespondentDo-Hyun Kim
BT Solutions, Inc. Unit 904, Eonju-ro 86-gil 5, Gangnam-gu Seoul,  KR 06210
Product CodeOHS  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-08-05
Decision Date2022-11-03

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