# K111882: Laminar Flow Phaco Tips

- Pathway: 510(k) (Abbreviated)
- Applicant: Abbott Medical Optics, Inc.
- Decided: Nov 7, 2011 after 129 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 K951462 (1995). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951462: Amo Profinesse Iii Ultrasonic Handpiece System, Allergan Medical Optics (1995) 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 Lamninar Flow Phacoemulsification Needles (Tips) are used to break up (emulsify) the nucleus of a cataractous lens and remove the remaining nuclear fragments.

Source page: https://510kreport.com/device/K111882
Methodology: https://510kreport.com/methodology