# K961242: Amo Phacoflex II Intersection System

- Pathway: 510(k) (Traditional)
- Applicant: Allergan, Inc.
- Decided: Jun 17, 1996 after 77 days
- Product code: KYB (Lens, Guide, Intraocular)
- Device class: 1
- Regulation: 21 CFR 886.4300
- 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 K930320 (1994). 2 ancestors in all.
31 later devices descend from it; 4 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K941603: Amo Phacoflex Inserter Disposable Cartridge, and Handpiece, Allergan Medical Optics (1994) Summary page 1.
- K930320: Amo Phacoflex Inserter, Foldable Iol Insert Instr, Allergan Medical Optics (1994) Summary page 1.

## Most influential descendants
- K040837: Multiject Injector and Microglide Cartridge (2004), 25 descendants of its own
- K070669: Iol Injector Set (2007), 19 descendants of its own
- K092023: Naviject SUB2-1P, Model: LP604430 (2009), 18 descendants of its own
- K113852: Bausch & Lomb Iol Injector (2012), 12 descendants of its own
- K050638: Lenstec Intraocular Lens (Iol) Injection System for Tetraflex Intraocular Lenses (2005), 12 descendants of its own

## Indications for use
The AMO®PhacoFlex® II Insertion System is used to fold and assist in inserting the AMO®PhacoFlex® II (SLM-2/UV) family of intraocular lenses, specifically the SI-30NB and SI-40NB, into the eye.

Source page: https://510kreport.com/device/K961242
Methodology: https://510kreport.com/methodology