FDA 510(k) Application Details - K163632

Device Classification Name	Lens, Surgical, Laser, Accesssory, Ophthalmic Laser   More FDA Info for this Device
510(K) Number	K163632
Device Name	Lens, Surgical, Laser, Accesssory, Ophthalmic Laser
Applicant	Katalyst Surgical, LLC 754 Goddard Avenue Chesterfield, MO 63005 US Other 510(k) Applications for this Company
Contact	Meryl Koch Other 510(k) Applications for this Contact
Regulation Number	886.4390   More FDA Info for this Regulation Number
Classification Product Code	LQJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/22/2016
Decision Date	06/15/2017
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