# K082845: Infiniti Vision System with Ozil IP

- Pathway: 510(k) (Traditional)
- Applicant: Alcon Research, Ltd.
- Decided: Feb 12, 2009 after 139 days
- Product code: HQC (Unit, Phacofragmentation)
- Device class: 2
- Regulation: 21 CFR 886.4670
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K844373 (1985). 15 ancestors in all.
22 later devices descend from it; 5 cite it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021566: Infiniti, Alcon Laboratories, Inc. (2002) Summary page 1.
- K981116: Sovereign Cataract Extraction System, Allergan, Inc. (1998) Summary page 1.
- K063583: Alcon Vision System, Alcon (2008) Summary page 1.
- K911808: Gemini Ophthalmic Surgery System, Alcon Laboratories (1991) Summary page 1.

## Most influential descendants
- K102727: Lensar Laser System for Anterior Capsulotomy (2011), 12 descendants of its own
- K112425: Infiniti Vision System Evergreen II Autosert Iol Injector Handpiece (2011), 8 descendants of its own
- K112098: TBD (2011), 7 descendants of its own
- K121555: Centurion Vision System (2012), 6 descendants of its own
- K120214: TBD (2012), 6 descendants of its own

## Indications for use
The Infiniti®Vision System with OZil®IP is indicated for emulsification and removal of cataracts, vitreous aspiration and cutting associated with anterior vitrectomy, and bipolar coagulation.

Source page: https://510kreport.com/device/K082845
Methodology: https://510kreport.com/methodology