FDA 510(k) Application Details - K223685

Device Classification Name	Powered Laser Surgical Instrument   More FDA Info for this Device
510(K) Number	K223685
Device Name	Powered Laser Surgical Instrument
Applicant	Jeisys Medical Inc 307, 308, 401, Daeryung Techno Town 8th, 96, Gamasan-ro, Geumcheon-Gu Seoul 08501 KR Other 510(k) Applications for this Company
Contact	Sang Hoon Hwang 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	12/09/2022
Decision Date	01/04/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review