FDA 510(k) Application Details - K240537

Device Classification Name	Powered Laser Surgical Instrument   More FDA Info for this Device
510(K) Number	K240537
Device Name	Powered Laser Surgical Instrument
Applicant	El.En. S.p.A. Via Baldanzese 17 Calenzano 50141 IT Other 510(k) Applications for this Company
Contact	Paolo Peruzzi 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	02/26/2024
Decision Date	03/20/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review