FDA 510(k) Application Details - K213658

Device Classification Name	Laser, Dental, Soft Tissue   More FDA Info for this Device
510(K) Number	K213658
Device Name	Laser, Dental, Soft Tissue
Applicant	El.En Electronic Engineering Spa Via Baldanzese 17 Calenzano, FL 50041 US 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	NVK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/19/2021
Decision Date	03/11/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review