510(k) Report

FDA applicant

Bioptigen, Inc.

Morrisville, NC4 decisions2006–20160 recalls

FDA records 4 decisions for Bioptigen, Inc. (Morrisville, NC) from 2006 to 2016: 4 510(k) clearances. Most are in product codes HLI (Ophthalmoscope, Ac-Powered) and OBO (Tomography, Optical Coherence). Its devices cite 5 predicates, 3 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, ophthalmic panel, where it files most

How often FDA has decided Bioptigen, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2012: 12015: 12016: 1
2007high 1 (2012) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Bioptigen, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • HLIOphthalmoscope, Ac-Powered3decisions
  • OBOTomography, Optical Coherence1decision

Whose devices does it build on?

Its devices cite 5 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 3 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K120057Envisu Spectral Domain Ophthalmic Imaging System (Sdois)Bioptigen, Inc. · 20123cite it
  • K063343Bioptigen Spectral Domain Ophthalmic Imaging SystemBioptigen, Inc. · 20062cite it
  • K150722EnFocus 2300, EnFocus 4400Bioptigen, Inc. · 20151cites it

What has FDA decided for it lately?

  • K162783EnFocus 2300, EnFocus 4400Bioptigen, Inc. · 2016
  • K150722EnFocus 2300, EnFocus 4400Bioptigen, Inc. · 2015
  • K120057Envisu Spectral Domain Ophthalmic Imaging System (Sdois)Bioptigen, Inc. · 2012
  • K063343Bioptigen Spectral Domain Ophthalmic Imaging SystemBioptigen, Inc. · 2006

All 4 as Bioptigen, Inc. →