510(k) Report

FDA applicant

VitreQ BV

Vierpolders, NL2 decisions2019–20201 recall

FDA records 2 decisions for VitreQ BV (Vierpolders, NL) from 2019 to 2020: 2 510(k) clearances. Most are in product codes HQB (Photocoagulator And Accessories) and HPS (Unit, Cryophthalmic). Its devices cite 4 predicates, 0 of them its own earlier devices. 1 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 VitreQ BV’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2019: 12020: 1
2019high 1 (2019) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

1in 2023

2023: 1
2019high 1 (2023) · low 0 (2019)2026

Class I Class II/III not classified

FIG. 1 — VitreQ BV by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • HQBPhotocoagulator And Accessories1decision
  • HPSUnit, Cryophthalmic1decision

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K202038CryoTreQVitreQ BV · 20201 recall
  • K182646Vitreq disposable laser probes, light fibers and ChandelierVitreQ BV · 2019

All 2 as VitreQ BV →

What has been recalled?

1 recall linked to its devices; the latest:

  • K202038CryoTreQ- Aa disposable handheld instrument intended for ophthalmic surgery. It creates…Mar 17, 2023Class II