FDA 510(k) Application Details - K203799

Device Classification Name	Powered Laser Surgical Instrument   More FDA Info for this Device
510(K) Number	K203799
Device Name	Powered Laser Surgical Instrument
Applicant	InnovaQuartz LLC 23030 N. 15th Ave Phoenix, AZ 85027 US Other 510(k) Applications for this Company
Contact	Stephen Griffin 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	12/28/2020
Decision Date	09/20/2021
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