FDA 510(k) Application Details - K191846

Device Classification Name	Photocoagulator And Accessories   More FDA Info for this Device
510(K) Number	K191846
Device Name	Photocoagulator And Accessories
Applicant	Vortex Surgical Inc. 680 Crown Industrial Ct. Suite F Chesterfield, MO 63005 US Other 510(k) Applications for this Company
Contact	Bob Neu Other 510(k) Applications for this Contact
Regulation Number	886.4690   More FDA Info for this Regulation Number
Classification Product Code	HQB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/10/2019
Decision Date	12/23/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review