FDA 510(k) Application Details - K213594

Device Classification Name	Powered Laser Surgical Instrument   More FDA Info for this Device
510(K) Number	K213594
Device Name	Powered Laser Surgical Instrument
Applicant	ELESTA SPA Via Baldanzese 17 Calenzano 50041 IT Other 510(k) Applications for this Company
Contact	Fabio Andreola 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	11/12/2021
Decision Date	05/03/2022
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