# Biovision, Inc.

- Location (FDA's records): Irvine, CA
- FDA decisions: 6 (1990–2004): 6 510(k) clearances
- Names in FDA's records: Biovision, Inc. (3); Biovision AG (2); Biovision GmbH (1)
- Product codes: HNO (2), GEX (2), DZL (1), IYO (1)
- Predicates its devices cite: 5 (1 its own); citations of its devices by later devices: 7 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Bausch & Lomb, Inc.: 1 (https://510kreport.com/company/bausch-lomb)
- Interpore Intl.: 1 (https://510kreport.com/company/interpore-intl)
- The Straumann Co.: 1 (https://510kreport.com/company/straumann)
- Intra Lase Corp.: 1 (https://510kreport.com/company/intra-lase)

## Firms that cite its devices most
- Gebauer Medizintechnik GmbH: 2 (https://510kreport.com/company/gebauer-medizintechnik)
- Imtec Corp.: 1 (https://510kreport.com/company/imtec)
- Quantel Medical: 1 (https://510kreport.com/company/quantel-medical)
- Schwind Eye-Tech-Solutions GmbH & Co. KG: 1 (https://510kreport.com/company/schwind-eye-tech-solutions)
- Carl Zeiss, Inc.: 1 (https://510kreport.com/company/carl-zeiss)

## Its most-cited devices
- K014000: Vistitome 20-10 Microkeratome (2002), cited by 3
- K926251: B-Scan Opthalmic Ultrasound Imaging System (1993), cited by 2
- K974392: Leadfix Bioresorbable Membrance Pin System (1998), cited by 1
- K042083: Modification to Visitome 20-10 Microkeratome (2004), cited by 1

## Recent decisions
- K042083: Modification to Visitome 20-10 Microkeratome (Nov 16, 2004)
- K014000: Vistitome 20-10 Microkeratome (Mar 11, 2002)
- K974392: Leadfix Bioresorbable Membrance Pin System (Jan 30, 1998)
- K926251: B-Scan Opthalmic Ultrasound Imaging System (Sep 14, 1993)
- K910027: Crystal Focus Emerald Laser SLT MCX 1.5 Convex Pro (Sep 25, 1991)
- K901636: Diamond ND:Yag Ophthalmic Laser (Jun 22, 1990)

Source page: https://510kreport.com/company/biovision