# K080803: Visual Phacoemulsification System, Model 551

- Pathway: 510(k) (Traditional)
- Applicant: American Optisurgical, Inc.
- Decided: Sep 22, 2008 after 185 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: 2 generations back to K931354 (1994). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020527: Horizon Phacoemulsification System, Model HZN-2030, American Optisurgical, Inc. (2002) Summary page 1.

## Indications for use
The VizualTM Phacoemulsification System is intended for use in the disruption and extraction of cataractous lens material from the eye with ultrasonic energy; a process known as phacoemulsification.

Source page: https://510kreport.com/device/K080803
Methodology: https://510kreport.com/methodology