510(k) Report

FDA applicant

Zeta Development Laboratories

El Dorado Hills, CA1 decision2002–20020 recalls

FDA records 1 decision for Zeta Development Laboratories (El Dorado Hills, CA) in 2002: 1 510(k) clearance. All are in product code HKI (Camera, Ophthalmic, Ac-Powered). Its devices cite 4 predicates, 0 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 Zeta Development Laboratories’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Zeta Development Laboratories since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Zeta Development Laboratories 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?

  • HKICamera, Ophthalmic, Ac-Powered1decision

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K022164Zeta Diagnostic Retinal Imaging SystemZeta Development Laboratories · 20021cites it

What has FDA decided for it lately?

  • K022164Zeta Diagnostic Retinal Imaging SystemZeta Development Laboratories · 2002

The one decision as Zeta Development Laboratories →

Other applicant names beginning “Zeta”

FDA records each applicant name separately; these may or may not be the same firm.

Zeta Surgical, Inc. 6