# Oculus Optikgerate GmbH

- Location (FDA's records): Wetzlar, DE
- FDA decisions: 8 (2003–2026): 8 510(k) clearances
- Names in FDA's records: Oculus Optikgerate GmbH (6); Oculus Optikgeräte GmbH (2)
- Product codes: MXK (7), HKX (1)
- Predicates its devices cite: 12 (6 its own); citations of its devices by later devices: 11 (6 its own)
- Recalls linked to its devices: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Nidek, Inc.: 2 (https://510kreport.com/company/nidek)
- Optovue, Inc.: 1 (https://510kreport.com/company/optovue)
- Luneau SA: 1 (https://510kreport.com/company/luneau)
- Carl Zeiss Meditec, AG: 1 (https://510kreport.com/company/carl-zeiss-meditec)
- Surgical Instruments Service and Savings, Inc.: 1 (https://510kreport.com/company/surgical-instruments-service-and-savings)

## Firms that cite its devices most
- Optovue, Inc.: 1 (https://510kreport.com/company/optovue)
- Nidek, Inc.: 1 (https://510kreport.com/company/nidek)
- Sis Ag, Surgical Instrument Systems: 1 (https://510kreport.com/company/sis-ag-surgical-instrument-systems)
- Wavelight AG: 1 (https://510kreport.com/company/wavelight)
- Luneau SA: 1 (https://510kreport.com/company/luneau)

## Its most-cited devices
- K030719: Pentacam Scheimpflug Camera (2003), cited by 5
- K152311: Pentacam AXL (2016), cited by 3
- K041841: Pachycam (2005), cited by 2
- K073508: Parkone (2008), cited by 1

## Recent decisions
- K251848: Pentacam® Cornea OCT (Mar 13, 2026)
- K202989: Myopia Master (Jul 14, 2021)
- K201724: Pentacam AXL Wave (Oct 21, 2020)
- K152311: Pentacam AXL (Jan 20, 2016)
- K113066: Corvis ST (Nov 8, 2012)
- K073508: Parkone (Sep 11, 2008)
- K041841: Pachycam (Jan 28, 2005)
- K030719: Pentacam Scheimpflug Camera (Sep 16, 2003)

Source page: https://510kreport.com/company/oculus-optikgerate