FDA 510(k) Application Details - K250281

Device Classification Name	Powered Light Based Non-Laser Surgical Instrument With Thermal Effect   More FDA Info for this Device
510(K) Number	K250281
Device Name	Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
Applicant	El.En. S.p.A. Via Baldanzese 17 Calenzano 50041 IT Other 510(k) Applications for this Company
Contact	Peruzzi Paolo Other 510(k) Applications for this Contact
Regulation Number	878.4810   More FDA Info for this Regulation Number
Classification Product Code	ONF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/31/2025
Decision Date	02/26/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review