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FDA 510(k) Application Details - K230268
Device Classification Name
Powered Laser Surgical Instrument
More FDA Info for this Device
510(K) Number
K230268
Device Name
Powered Laser Surgical Instrument
Applicant
Bluecore Company Co Ltd
Ace Hightech 21 #1203
48, Centurm Jungang-ro, Haeundae-gu
Busan 48059 KR
Other 510(k) Applications for this Company
Contact
Bill 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
01/31/2023
Decision Date
08/10/2023
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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