510(k) Report

FDA applicant

Gulden Ophthalmics

Elkins Park, PA1 decision1997–199713 recalls

FDA records 1 decision for Gulden Ophthalmics (Elkins Park, PA) in 1997: 1 510(k) clearance. All are in product code HPZ (Implant, Eye Sphere). Its devices cite 1 predicate, 0 of them its own earlier devices. 13 recalls are 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 Gulden Ophthalmics’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Gulden Ophthalmics since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Gulden Ophthalmics 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?

  • HPZImplant, Eye Sphere1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 0 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.

  • K972661Eye Sphere, ConformersGulden Ophthalmics · 19972cite it

What has FDA decided for it lately?

  • K972661Eye Sphere, ConformersGulden Ophthalmics · 199713 recalls

The one decision as Gulden Ophthalmics →

What has been recalled?

13 recalls linked to its devices; the latest:

  • K972661Venus Eye Sphere 12 mm (Sterile)Nov 29, 2002
  • K972661Venus Eye Sphere 14 mm (Sterile)Nov 29, 2002
  • K972661Venus Eye Sphere 18 mm (Sterile)Nov 29, 2002
  • K972661Conformer - Small (Sterile)Nov 29, 2002
  • K972661Conformer - Medium (Sterile)Nov 29, 2002
  • K972661Conformer - Large (Sterile)Nov 29, 2002