Panels › Ophthalmic › Product code MXK · Class 2
Device, Analysis, Anterior Segment
Regulation 886.1850
2510(k)s in 12 months (23 all time)
0recalls in 12 months (7 all time)
7recalls that name a 510(k)
Top companies in MXK
| Company | 510(k)s | Recalls |
|---|---|---|
| Oculus Optikgeraete GMBH | 0 | 7 |
| Oculus Optikgerate GmbH | 5 | 0 |
| Heidelberg Engineering | 2 | 0 |
| Oculus Optikgeräte GmbH | 2 | 0 |
| Santec Corporation | 2 | 0 |
| Sis Ag, Surgical Instrument Systems | 2 | 0 |
| Visia Imaging S.R.L. | 2 | 0 |
| Bausch & Lomb | 1 | 0 |
| Haag-Streit Holding AG | 1 | 0 |
| Intelon Optics, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 13, 2026 | K251848 | Pentacam® Cornea OCT Oculus Optikgeräte GmbH, DE | MXK |
| Dec 18, 2025 | K252348 | Tomey Optical Biometer OA-2000 (OA-2000) Tomey Corporation, JP | MXK |
| Aug 16, 2024 | K223700 | BOSS Intelon Optics, Inc. | MXK |
| Jun 29, 2023 | K222933 | MYAH Visia Imaging S.R.L., IT | MXK |
| Mar 1, 2022 | K211868 | MYAH Visia Imaging S.R.L., IT | MXK |
| Jul 14, 2021 | K202989 | Myopia Master Oculus Optikgeräte GmbH, DE | MXK |
| Oct 21, 2020 | K201724 | Pentacam AXL Wave Oculus Optikgerate GmbH, DE | MXK |
| Jul 25, 2019 | K182659 | Galilei G6 Lens Professional Sis Ag, Surgical Instrument Systems, CH | MXK |
| May 16, 2019 | K191051 | ARGOS Santec Corporation, JP | MXK |
| Jan 20, 2016 | K152311 | Pentacam AXL Oculus Optikgerate GmbH, DE | MXK |
| Oct 2, 2015 | K150754 | ARGOS Santec Corporation, JP | MXK |
| Sep 11, 2008 | K073508 | PARKONE Oculus Optikgerate GmbH, DE | MXK |
| Jul 20, 2007 | K071183 | ALLEGRO OCULYZER Wavelight AG, DE | MXK |
| Jan 13, 2006 | K052935 | HEIDELBERG ENGINEERING SLITLAMP-OCT (SL-OCT) Heidelberg Engineering, DE | MXK |
| Sep 28, 2005 | K051940 | CM 3910 ROTATING DOUBLE SCHEIMPFLUG CAMERA Sis Ltd., Surgical Instrument Systems | MXK |
| Jan 28, 2005 | K041841 | PACHYCAM Oculus Optikgerate GmbH, DE | MXK |
| Oct 13, 2004 | K042742 | HEIDELBERG RETINA TOMOGRAPH II / ROSTOCK CORNEA MODULE (HRT II / RCM) Heidelberg Engineering, DE | MXK |
| Sep 2, 2004 | K031788 | PATHFINDER Massie Research Laboratories, Inc. | MXK |
| Jul 23, 2004 | K040913 | NGDI (NEXT GENERATION DIAGNOSTIC INSTRUMENT) Bausch & Lomb | MXK |
| Sep 25, 2003 | K030393 | OPTICAL LOW COHERENCE REFLECTOMETRY (OLCR) PACHYMETER Haag-Streit Holding AG | MXK |
| Sep 16, 2003 | K030719 | PENTACAM SCHEIMPFLUG CAMERA Oculus Optikgerate GmbH | MXK |
| Aug 6, 1999 | K991284 | ANTERIOR EYE-SEGMENT ANALYSIS SYSTEM Nidek, Inc. | MXK |
| Mar 5, 1999 | K984443 | ORBSCAN Technolas Perfect Vision GmbH | MXK |
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