510(k) Report

FDA applicant

Lumiscope Co., Inc.

Edison, NJ13 decisions1988–20030 recalls

FDA records 13 decisions for Lumiscope Co., Inc. (Edison, NJ) from 1988 to 2003: 13 510(k) clearances. Most are in product codes GZJ (Stimulator, Nerve, Transcutaneous, For Pain…) and FLL (Continuous Measurement Thermometer). 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, neurology panel, where it files most

How often FDA has decided Lumiscope Co., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Lumiscope Co., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Lumiscope Co., 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?

  • GZJStimulator, Nerve, Transcutaneous, For Pain Relief3decisions
  • FLLContinuous Measurement Thermometer2decisions
  • ILYLamp, Infrared, Therapeutic Heating1decision
  • FNMMattress, Air Flotation, Alternating Pressure1decision
  • CAFNebulizer (Direct Patient Interface)1decision
  • LIHInterferential Current Therapy1decision

Also: BTI (1), GXY (1), DRT (1), IPF (1).

Who builds on its devices?

Later devices cite its devices 4 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.

  • K894127Lumiscope Model 1000/Apcc Model 1000Lumiscope Co., Inc. · 19892cite it
  • K954792Lumiscope Model 2018 ThermometerLumiscope Co., Inc. · 19961cites it
  • K924081LumisonicLumiscope Co., Inc. · 19921cites it

What has FDA decided for it lately?

  • K032714Cardicare Model MT-301F & MT-301CLumiscope Co., Inc. · 2003
  • K954792Lumiscope Model 2018 ThermometerLumiscope Co., Inc. · 1996
  • K931768Interferential Current Therapy UnitLumiscope Co., Inc. · 1994
  • K925054Infrared LampLumiscope Co., Inc. · 1993
  • K924081LumisonicLumiscope Co., Inc. · 1992
  • K920099GymmanLumiscope Co., Inc. · 1992
  • K901849Lumiscope Ems 8000Lumiscope Co., Inc. · 1990
  • K901096Lumiscope Alternating Pressure Pad & PumpLumiscope Co., Inc. · 1990

All 13 as Lumiscope Co., Inc. →