FDA 510(k) Application Details - K210827

Device Classification Name	More FDA Info for this Device
510(K) Number	K210827
Device Name	ZEPTO Precision Capsulotomy System
Applicant	Centricity Vision, Inc. 1939 Palomar Oaks Way, Suite A Carlsbad, CA 92011 US Other 510(k) Applications for this Company
Contact	Neal Hartman Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PUL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/19/2021
Decision Date	12/14/2021
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