# K050518: Reprocessed Phacoemuisification Tips

- Pathway: 510(k) (Traditional)
- Applicant: Alliance Medical, Inc.
- Decided: Sep 23, 2005 after 206 days
- Product code: NKX (Needle, Phacoemulsification, Reprocessed)
- 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 K911808 (1991). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K911808: Gemini Ophthalmic Surgery System, Alcon Laboratories (1991) Summary page 1.

## Indications for use
Reprocessed Phacoemulsification Tips are indicated for use to emulsify and excise cataract tissues in patients requiring eye surgery.

Source page: https://510kreport.com/device/K050518
Methodology: https://510kreport.com/methodology