FDA 510(k) Application Details - K210350

Device Classification Name	Laser, Dental, Soft Tissue   More FDA Info for this Device
510(K) Number	K210350
Device Name	Laser, Dental, Soft Tissue
Applicant	Azena Medical, LLC 3021 Citrus Circle Suite 180 Walnut Creek, CA 94598 US Other 510(k) Applications for this Company
Contact	Lindsay Tilton 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	02/08/2021
Decision Date	11/18/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review