# K103023: Unit, Phacofragmentation

- Pathway: 510(k) (Abbreviated)
- Applicant: Abbott Medical Optics, Inc.
- Decided: Jun 1, 2011 after 232 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: 1 generation back to K840695 (1984). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K844373: O.M.S. Ultra-Phaco, Optical Micro Systems, Inc. (1985) Summary page 1.
- K840695: Phacoemulsification Kits, Innovative Surgical Products, Inc. (1984) Summary page 1.

## Most influential descendants
- K121721: Laminar Flow Phaco Tips and Irrigation Sleeve (21G, Reusable) (2012), 1 descendant of its own
- K192418: Phacoemulsification Needle (Tip) and Irrigation Sleeve (2020), 0 descendants of its own

## Indications for use
The irrigation sleeve is a device intended to direct irrigation solution across the shaft of a phacoemulsification tip, allowing the solution to enter the eye during ocular surgery.

Source page: https://510kreport.com/device/K103023
Methodology: https://510kreport.com/methodology