FDA 510(k) Application Details - K212763

Device Classification Name	Instrument, Vitreous Aspiration And Cutting, Ac-Powered   More FDA Info for this Device
510(K) Number	K212763
Device Name	Instrument, Vitreous Aspiration And Cutting, Ac-Powered
Applicant	VisionCare Devices, LLC. 6100 Bellevue Lane Anderson, CA 96007 US Other 510(k) Applications for this Company
Contact	Rick Morgan Other 510(k) Applications for this Contact
Regulation Number	886.4150   More FDA Info for this Regulation Number
Classification Product Code	HQE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/31/2021
Decision Date	08/10/2022
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