FDA applicant

Biovision, Inc.

Irvine, CA6 decisions1990–20040 recalls

FDA records 6 decisions for Biovision, Inc. (Irvine, CA) from 1990 to 2004: 6 510(k) clearances. Most are in product codes HNO (Keratome, Ac-Powered) and GEX (Powered Laser Surgical Instrument). Its devices cite 5 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Biovision AG”, “Biovision GmbH”.

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 Biovision, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Biovision, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Biovision, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Biovision, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Biovision”

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

Biovision Technologies, LLC 3

Biovision, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Biovision”