510(k) Report

FDA applicant

Beaver Visitec International, Inc.

Waltham2 decisions2025–20251 recall

FDA records 2 decisions for Beaver Visitec International, Inc. (Waltham) in 2025: 1 510(k) clearance and 1 original PMA approval. Most are in product codes HQL (Intraocular Lens) and HQF (Laser, Ophthalmic). Its devices cite 2 predicates, 0 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Beaver-Visitec International, Inc.”.

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 Beaver Visitec International, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2025: 2
2025high 2 (2025)2026

2026 so far, outlined.

Recalls per year

1in 2025

2025: 1
2025high 1 (2025)2026

Class I Class II/III not classified

FIG. 1 — Beaver Visitec International, Inc. by year, 2025–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • HQLIntraocular Lens1decision
  • HQFLaser, Ophthalmic1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • P240038FINEVISION HP Trifocal IOLsBeaver Visitec International, Inc. · 2025
  • K240615Leos Laser and Endoscopy SystemBeaver-Visitec International, Inc. · 20251 recall

The one decision as Beaver Visitec International, Inc. →The one decision as Beaver-Visitec International, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K240615BVI Leos Laser and Endoscopy System. Model Number: OME6000U.Dec 5, 2025Class II