Data / Medical devices / Device, Analysis, Anterior Segment
Device, Analysis, Anterior Segment (MXK): 14 FDA-registered makers in 7 countries
14 establishments in 7 countries are registered with the FDA to make Device, Analysis, Anterior Segment (product code MXK, Class 2, 21 CFR 886.1850). 8 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 23 510(k) clearances under this code, the latest on March 13, 2026, and lists 3 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- MXK
- Device class
- 2
- Regulation
- 886.1850
- Medical specialty
- Ophthalmic
Makers by country
| Country | Makers |
|---|---|
| Germany | 3 |
| Japan | 3 |
| Italy | 2 |
| Switzerland | 2 |
| United States | 2 |
| France | 1 |
| Israel | 1 |
Makers of Device, Analysis, Anterior Segment
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Oculus Optikgerate GMBH | WETZLAR Hesse, Germany | Manufacturer | 5 | March 13, 2026 | 0 | 3 | 0 | api.fda.gov |
| VISIA imaging S.r.l. | San Giovanni Valdarno Arezzo, Italy | Manufacturer | 2 | June 29, 2023 | 0 | 0 | 0 | api.fda.gov |
| Ziemer Ophthalmic Systems AG | PORT Bern, Switzerland | Manufacturer | 2 | July 25, 2019 | 0 | 0 | 0 | api.fda.gov |
| Ziemer Opthalmic Systems AG | Bruegg Bern, Switzerland | Manufacturer | 2 | July 25, 2019 | 0 | 0 | 0 | api.fda.gov |
| santec OIS Corporation | Komaki Aichi, Japan | Manufacturer | 2 | May 16, 2019 | 0 | 0 | 0 | api.fda.gov |
| Bausch & Lomb Incorporated | Saint Louis, MO, United States | Remanufacturer | 1 | March 5, 1999 | 0 | 0 | 0 | api.fda.gov |
| Heidelberg Engineering GMBH | HEIDELBERG Baden-Wurttemberg, Germany | Manufacturer | 1 | October 13, 2004 | 0 | 0 | 0 | api.fda.gov |
| Intelon Optics | Woburn, MA, United States | Manufacturer | 1 | August 16, 2024 | 0 | 0 | 0 | api.fda.gov |
| C.S.O. S.R.L. | Scandicci Firenze, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Eurofins STERIPAC GMBH | Calw-Altburg Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Luneau Technology Operations | Pont-de-l'Arche Eure, France | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Topcon Corp. | Tokyo, Japan | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Topcon Yamagata Co., LTD | Yamagata-KEN, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Visionix Ltd. | Jerusalem, Israel | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated March 13, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.