# Bioptigen, Inc.

- Location (FDA's records): Morrisville, NC
- FDA decisions: 4 (2006–2016): 4 510(k) clearances
- Product codes: HLI (3), OBO (1)
- Predicates its devices cite: 5 (3 its own); citations of its devices by later devices: 6 (3 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
- Carl Zeiss Meditec, AG: 1 (https://510kreport.com/company/carl-zeiss-meditec)
- Carl Zeiss Ophthalmic Systems, Inc.: 1 (https://510kreport.com/company/carl-zeiss-ophthalmic-systems)

## Firms that cite its devices most
- Optovue, Inc.: 1 (https://510kreport.com/company/optovue)
- Heidelberg Engineering GmbH: 1 (https://510kreport.com/company/heidelberg-engineering)
- Optomedical Technologies GmbH: 1 (https://510kreport.com/company/optomedical-technologies)

## Its most-cited devices
- K120057: Envisu Spectral Domain Ophthalmic Imaging System (Sdois) (2012), cited by 3
- K063343: Bioptigen Spectral Domain Ophthalmic Imaging System (2006), cited by 2
- K150722: EnFocus 2300, EnFocus 4400 (2015), cited by 1

## Recent decisions
- K162783: EnFocus 2300, EnFocus 4400 (Dec 9, 2016)
- K150722: EnFocus 2300, EnFocus 4400 (Dec 2, 2015)
- K120057: Envisu Spectral Domain Ophthalmic Imaging System (Sdois) (May 11, 2012)
- K063343: Bioptigen Spectral Domain Ophthalmic Imaging System (Dec 13, 2006)

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