Easy Claire

Light Based Over The Counter Wrinkle Reduction

Y&J BIO Co., Ltd.

The following data is part of a premarket notification filed by Y&j Bio Co., Ltd. with the FDA for Easy Claire.

Pre-market Notification Details

Device IDK223278
510k NumberK223278
Device Name:Easy Claire
ClassificationLight Based Over The Counter Wrinkle Reduction
Applicant Y&J BIO Co., Ltd. B-916, 947, Hanam-daero Hanam-si,  KR 12982
ContactYoungsam Chun
CorrespondentPaweena U-Thainual
MDR Solutions Co., Ltd. 1435 Kanjanapisek Rd., Bang Khae Nuea Bang Khae,  TH 10160
Product CodeOHS  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-10-24
Decision Date2022-11-17

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