510(k) Report

FDA applicant

Osyris

Hellemmes, FR3 decisions2008–20080 recalls

FDA records 3 decisions for Osyris (Hellemmes, FR) in 2008: 3 510(k) clearances. All are in product code GEX (Powered Laser Surgical Instrument). Its devices cite 4 predicates, 1 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, general and plastic surgery panel, where it files most

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

FDA decisions per year

3in 2008

2008: 3
2008high 3 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Osyris 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?

  • GEXPowered Laser Surgical Instrument3decisions

Whose devices does it build on?

Its devices cite 4 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 1 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.

  • K073617Pharaon LipoOsyris · 20087cite it

What has FDA decided for it lately?

  • K082004Smoothkit+Osyris · 2008
  • K080731Pharaon 980 Endo/Exo, Osyfibre 600, CONTROL4+ HandpieceOsyris · 2008
  • K073617Pharaon LipoOsyris · 2008

All 3 as Osyris →

Other applicant names beginning “Osyris”

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

Osyris Medical 1