FDA 510(k) Applications for Medical Device Product Code: MXK (Device,Analysis,Anterior Segment)

FDA 510(k) Applications for Medical Device Product Code "MXK"
(Device,Analysis,Anterior Segment)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K040913	BAUSCH & LOMB	NGDI (NEXT GENERATION DIAGNOSTIC INSTRUMENT)	07/23/2004
K030393	HAAG-STREIT HOLDING AG	OPTICAL LOW COHERENCE REFLECTOMETRY (OLCR) PACHYMETER	09/25/2003
K052935	HEIDELBERG ENGINEERING	HEIDELBERG ENGINEERING SLITLAMP-OCT (SL-OCT)	01/13/2006
K042742	HEIDELBERG ENGINEERING	HEIDELBERG RETINA TOMOGRAPH II / ROSTOCK CORNEA MODULE (HRT II / RCM)	10/13/2004
K223700	Intelon Optics, Inc.	BOSSÖ	08/16/2024
K031788	MASSIE RESEARCH LABORATORIES, INC.	PATHFINDER	09/02/2004
K991284	NIDEK, INC.	ANTERIOR EYE-SEGMENT ANALYSIS SYSTEM	08/06/1999
K041841	OCULUS OPTIKGERATE GMBH	PACHYCAM	01/28/2005
K073508	OCULUS OPTIKGERATE GMBH	PARKONE	09/11/2008
K152311	OCULUS OPTIKGERATE GMBH	Pentacam AXL	01/20/2016
K201724	OCULUS Optikgerate GmbH	Pentacam AXL Wave	10/21/2020
K030719	OCULUS OPTIKGERATE GMBH	PENTACAM SCHEIMPFLUG CAMERA	09/16/2003
K202989	OCULUS OptikgerΣte GmbH	Myopia Master	07/14/2021
K150754	SANTEC CORPORATION	ARGOS	10/02/2015
K191051	SANTEC CORPORATION	ARGOS	05/16/2019
K182659	SIS AG, Surgical Instrument Systems	Galilei G6 Lens Professional	07/25/2019
K051940	SIS LTD. SURGICAL INSTRUMENT SYSTEMS	CM 3910 ROTATING DOUBLE SCHEIMPFLUG CAMERA	09/28/2005
K984443	TECHNOLAS PERFECT VISION GMBH	ORBSCAN	03/05/1999
K222933	VISIA Imaging S.r.l.	MYAH	06/29/2023
K211868	VISIA imaging S.R.L.	MYAH	03/01/2022
K071183	WAVELIGHT AG	ALLEGRO OCULYZER	07/20/2007