# Optos Plc.

- Location (FDA's records): Washington, DC
- FDA decisions: 15 (1999–2024): 15 510(k) clearances
- Product codes: MYC (6), OBO (5), NFJ (2), HLI (2)
- 510(k) review time since 2016: median 132 days, against 175 for FDA's reviews in the same codes and years (3 of 5 faster)
- Predicates its devices cite: 27 (14 its own); citations of its devices by later devices: 19 (14 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Heidelberg Engineering GmbH: 2 (https://510kreport.com/company/heidelberg-engineering)
- Optovue, Inc.: 2 (https://510kreport.com/company/optovue)
- Rodenstock Instrument Corp.: 2 (https://510kreport.com/company/rodenstock-instrument)
- G. Rodenstock Instrumente GmbH: 2 (https://510kreport.com/company/g-rodenstock-instrumente)
- Topcon Medical Systems, Inc.: 1 (https://510kreport.com/company/topcon-medical-systems)
- Nidek Technologies Srl: 1 (https://510kreport.com/company/nidek-technologies)
- Odyssey Optical Systems, LLC: 1 (https://510kreport.com/company/odyssey-optical-systems)
- Carl Zeiss Meditec, AG: 1 (https://510kreport.com/company/carl-zeiss-meditec)

## Firms that cite its devices most
- Annidis Health Systems Corp.: 1 (https://510kreport.com/company/annidis-health-systems)
- Freedom Meditech, Inc.: 1 (https://510kreport.com/company/freedom-meditech)
- Nidek, Inc.: 1 (https://510kreport.com/company/nidek)
- Retinai Medical AG: 1 (https://510kreport.com/company/retinai-medical)
- Intelligent Retinal Imaging Systems, LLC: 1 (https://510kreport.com/company/intelligent-retinal-imaging-systems)

## Its most-cited devices
- K142897: P200DTx (2015), cited by 3
- K983999: PANORAMIC200 Opthalmoscope (1999), cited by 3
- K100644: Optos Limited Panoramic 200CAF (2010), cited by 2
- K102492: P200MAAF (2010), cited by 2
- K113696: Optos Advance (2012), cited by 2
- K173707: P200TE (2018), cited by 2

## Recent decisions
- K233602: P200TE (A10700) (May 9, 2024)
- K231673: P200TE (A10700) (Aug 18, 2023)
- K190732: P200TxE (Jul 31, 2019)
- K173707: P200TE (Feb 28, 2018)
- K162039: OptosAdvance 4.0 Software (Feb 8, 2017)
- K142897: P200DTx (Jan 16, 2015)
- K134039: Daytona Icg (P200TICG) (Apr 11, 2014)
- K121043: Optos Oct/Slo Microperimeter (Feb 22, 2013)

Source page: https://510kreport.com/company/optos