FDA 510(k) Application Details - K250504

Device Classification Name	Powered Laser Surgical Instrument   More FDA Info for this Device
510(K) Number	K250504
Device Name	Powered Laser Surgical Instrument
Applicant	CeramOptec GmbH Siemensstrasse 44 Bonn 53121 DE Other 510(k) Applications for this Company
Contact	Roland Dreschau 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	02/20/2025
Decision Date	07/14/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review