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FDA 510(k) Application Details - K223278
Device Classification Name
Light Based Over The Counter Wrinkle Reduction
More FDA Info for this Device
510(K) Number
K223278
Device Name
Light Based Over The Counter Wrinkle Reduction
Applicant
Y&J BIO Co., Ltd.
B-916, 947, Hanam-daero
Hanam-si 12982 KR
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Contact
Youngsam Chun
Other 510(k) Applications for this Contact
Regulation Number
878.4810
More FDA Info for this Regulation Number
Classification Product Code
OHS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/24/2022
Decision Date
11/17/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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