510(k) Report

FDA applicant

Perkinelmer Optoelectronics

Suunyvale, CA2 decisions1991–19980 recalls

FDA records 2 decisions for Perkinelmer Optoelectronics (Suunyvale, CA) from 1991 to 1998: 2 510(k) clearances. Most are in product codes GCT (Light Source, Endoscope, Xenon Arc) and FSS (Light, Surgical, Floor Standing). 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, gastroenterology and urology panel, where it files most

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

FDA decisions per year

No FDA decision for Perkinelmer Optoelectronics since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Perkinelmer Optoelectronics 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?

  • GCTLight Source, Endoscope, Xenon Arc1decision
  • FSSLight, Surgical, Floor Standing1decision

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.

  • K980044Xenon 300MXPerkinelmer Optoelectronics · 19981cites it

What has FDA decided for it lately?

  • K980044Xenon 300MXPerkinelmer Optoelectronics · 1998
  • K912354Olymous XLS Xenon Light SourcePerkinelmer Optoelectronics · 1991

All 2 as Perkinelmer Optoelectronics →

Other applicant names beginning “Perkinelmer”

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

Perkinelmer, Inc. 17Perkinelmer Life Sciences, Inc. 2