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 |
| K221601 | C.S.O. S.r.l. | MS-39 | 09/01/2023 |
| 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 |
| 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 |
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