510(k) Report

FDA applicant

Quantel S.A.

Bozeman, MT2 decisions2008–20100 recalls

FDA records 2 decisions for Quantel S.A. (Bozeman, MT) from 2008 to 2010: 2 510(k) clearances. Most are in product codes IYO (System, Imaging, Pulsed Echo, Ultrasonic) and GEX (Powered Laser Surgical Instrument). Its devices cite 3 predicates, 0 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, radiology panel, where it files most

How often FDA has decided Quantel S.A.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2008: 12010: 1
2008high 1 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Quantel S.A. by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • IYOSystem, Imaging, Pulsed Echo, Ultrasonic1decision
  • GEXPowered Laser Surgical Instrument1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 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.

  • K094038Compact TouchQuantel S.A. · 20102cite it

What has FDA decided for it lately?

  • K094038Compact TouchQuantel S.A. · 2010
  • K081095Prolite Iii Tower and PR and HR HandpieceQuantel S.A. · 2008

All 2 as Quantel S.A. →

Other applicant names beginning “Quantel”

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

Quantel Medical 33Quantel Derma GmbH 2