FDA 510(k) Application Details - K232133

Device Classification Name	Powered Laser Surgical Instrument   More FDA Info for this Device
510(K) Number	K232133
Device Name	Powered Laser Surgical Instrument
Applicant	CPMT Laser (Canadian Pioneer Medical Technology Corporation) 460 Garyray Drive, North York Toronto M9L 1P8 CA Other 510(k) Applications for this Company
Contact	Rashid Reza Mir Sayah 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	07/18/2023
Decision Date	04/16/2024
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