# K924235: Amo Elite

- Pathway: 510(k) (Traditional)
- Applicant: Allergan Medical Optics
- Decided: Dec 23, 1992 after 121 days
- Product code: HQC (Unit, Phacofragmentation)
- Device class: 2
- Regulation: 21 CFR 886.4670
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
60 later devices descend from it; 1 cites it directly.
0 of 61 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K981116: Sovereign Cataract Extraction System (1998), 59 descendants of its own
- K021566: Infiniti (2002), 50 descendants of its own
- K063583: Alcon Vision System (2008), 36 descendants of its own
- K063331: Bausch & Lomb NGX Microsurgical System (2006), 24 descendants of its own
- K082845: Infiniti Vision System with Ozil IP (2009), 22 descendants of its own

## Recalls of this device
- Mar 29, 2004 · Not classified · Z-0907-04: The lots are being recalled because the tray lid may not be adequately sealed under the red arrow in the upper right corner of the package tray. The blue wrapping within the tray may not be sterile an

Source page: https://510kreport.com/device/K924235
Methodology: https://510kreport.com/methodology