510(k) Report

FDA applicant

Precision Optics Corp.

Gardner, MA3 decisions1995–20060 recalls

FDA records 3 decisions for Precision Optics Corp. (Gardner, MA) from 1995 to 2006: 3 510(k) clearances. Most are in product codes HLJ (Ophthalmoscope, Battery-Powered) and HRX (Arthroscope). Its devices cite 2 predicates, 1 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 Precision Optics Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Precision Optics Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Precision Optics Corp. 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?

  • HLJOphthalmoscope, Battery-Powered1decision
  • HRXArthroscope1decision
  • EOBNasopharyngoscope (Flexible Or Rigid)1decision

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 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.

  • K053425Precision Optics Corporation Video Ophthalmoscope, Model 2500-VosPrecision Optics Corp. · 20061cites it
  • K945684Poc Arthroscope and AccessoriesPrecision Optics Corp. · 19951cites it

What has FDA decided for it lately?

  • K053425Precision Optics Corporation Video Ophthalmoscope, Model 2500-VosPrecision Optics Corp. · 2006
  • K983123Poc Ent Endoscope - SinuscopePrecision Optics Corp. · 1998
  • K945684Poc Arthroscope and AccessoriesPrecision Optics Corp. · 1995

All 3 as Precision Optics Corp. →