FDA 510(k) Application Details - K231901

Device Classification Name	Powered Laser Surgical Instrument   More FDA Info for this Device
510(K) Number	K231901
Device Name	Powered Laser Surgical Instrument
Applicant	Medical San Ind·stria de Equipamentos MΘdicos Ltda Rua Alberto Muller, 1100 Block 20 - Rooms 404 and 406 Lajeado 95913-528 BR Other 510(k) Applications for this Company
Contact	Francis Laion de Padua 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	06/28/2023
Decision Date	09/28/2023
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