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FDA 510(k) Application Details - K223778
Device Classification Name
Powered Laser Surgical Instrument
More FDA Info for this Device
510(K) Number
K223778
Device Name
Powered Laser Surgical Instrument
Applicant
Shanghai Omni Laser Skinology Co., Ltd.
Floor 3, Building 3, NO.227, Mingqiang Road,
Songjiang District
Shanghai 201612 CN
Other 510(k) Applications for this Company
Contact
Avril Ouyang
Other 510(k) Applications for this Contact
Regulation Number
878.4810
More FDA Info for this Regulation Number
Classification Product Code
GEX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/16/2022
Decision Date
03/31/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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