510(k) Report

FDA applicant

Full Spectrum, Inc.

Ames, IA3 decisions1996–19970 recalls

FDA records 3 decisions for Full Spectrum, Inc. (Ames, IA) from 1996 to 1997: 3 510(k) clearances. All are in product code GEX (Powered Laser Surgical Instrument). 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, general and plastic surgery panel, where it files most

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

FDA decisions per year

No FDA decision for Full Spectrum, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Full Spectrum, 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?

  • GEXPowered Laser Surgical Instrument3decisions

What has FDA decided for it lately?

  • K963991Fsi Laparoscopic Probe for All Fsi Ule-Overclad FF201 FibersFull Spectrum, Inc. · 1997
  • K963996(Fsi) Laparoscopic Probe for All Fsi Ule FF101 Fibers. Model Fsi FF101-LP-XXX, Where XXX = Fiber Diameters…Full Spectrum, Inc. · 1997
  • K955862Full Spectrum Ule-Overclad Fiber: Model 201Full Spectrum, Inc. · 1996

All 3 as Full Spectrum, Inc. →

Other applicant names beginning “Full”

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

Full Synergy Medical Products, Inc. 6Full Golden Biotech Corporation 2Full See Glasses Ind. Co., Ltd. 1Full Power Aed 1