510(k) Report

FDA applicant

Plancon Instruments

Antony, FR3 decisions1996–19980 recalls

FDA records 3 decisions for Plancon Instruments (Antony, FR) from 1996 to 1998: 3 510(k) clearances. All are in product code HNO (Keratome, Ac-Powered). Its devices cite 4 predicates, 3 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 Plancon Instruments’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Plancon Instruments since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Plancon Instruments 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?

  • HNOKeratome, Ac-Powered3decisions

Whose devices does it build on?

Its devices cite 4 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 14 times; 3 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.

  • K970377Plancon Microlamellar Keratome (Single Piece Keratome Head with Accessories)Plancon Instruments · 19977cite it
  • K980924Plancon Microlamellar Keratome EvolutionPlancon Instruments · 19984cite it
  • K960395Plancon Mircolamellar KeratomePlancon Instruments · 19963cite it

What has FDA decided for it lately?

  • K980924Plancon Microlamellar Keratome EvolutionPlancon Instruments · 1998
  • K970377Plancon Microlamellar Keratome (Single Piece Keratome Head with Accessories)Plancon Instruments · 1997
  • K960395Plancon Mircolamellar KeratomePlancon Instruments · 1996

All 3 as Plancon Instruments →