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FDA 510(k) Application Details - K230340
Device Classification Name
Powered Laser Surgical Instrument
More FDA Info for this Device
510(K) Number
K230340
Device Name
Powered Laser Surgical Instrument
Applicant
AMT Engineering Co., Ltd
811-812 Byoksan Technopia 560, Duchon Daero
Jungwon gu, SeongNam-si
Gyeonggi do 13230 KR
Other 510(k) Applications for this Company
Contact
SeoungSoo Choi
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
02/07/2023
Decision Date
05/04/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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