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FDA 510(k) Application Details - K220214
Device Classification Name
Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
More FDA Info for this Device
510(K) Number
K220214
Device Name
Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
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
ONF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/26/2022
Decision Date
02/18/2023
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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