510(k) Report

FDA applicant

Optimed, Inc.

Oakland, CA4 decisions1988–19900 recalls

FDA records 4 decisions for Optimed, Inc. (Oakland, CA) from 1988 to 1990: 4 510(k) clearances. Most are in product codes HPT (Perimeter, Automatic, Ac-Powered) and HLQ (Keratoscope, Ac-Powered). 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 Optimed, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Optimed, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Optimed, 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?

  • HPTPerimeter, Automatic, Ac-Powered2decisions
  • HLQKeratoscope, Ac-Powered1decision
  • KYFImplant, Eye Valve1decision

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.

  • K903462Optimed Glaucoma Pressure RegulatorOptimed, Inc. · 19901cites it

What has FDA decided for it lately?

  • K903462Optimed Glaucoma Pressure RegulatorOptimed, Inc. · 1990
  • K890687Ect-100 Electronic Corneal TopographerOptimed, Inc. · 1989
  • K884867Optifield I and II Automated PerimetersOptimed, Inc. · 1989
  • K883458Optimed AdvantageOptimed, Inc. · 1988

All 4 as Optimed, Inc. →

Other applicant names beginning “Optimed”

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

Optimed Technologies, Inc. 15Optimed Therapeutics 1