# K101134: Visian Nanopoint 2.0 Injector Model LP604430

- Pathway: 510(k) (Traditional)
- Applicant: Medicel AG
- Decided: Aug 9, 2010 after 109 days
- Product code: MSS (Folders And Injectors, Intraocular Lens (Iol))
- 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: 5 generations back to K930320 (1994). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092023: Naviject SUB2-1P, Model: LP604430, Medicel AG (2009) Summary page 1.

## Most influential descendants
- K231106: Accuject Refra Injector AR2900 (2023), 0 descendants of its own

## Indications for use
The Visian®(I nanoPOINT Tm 2.0 Injector System is a device intended to fold and insert STAAR Surgical Collamer® Phakic One Piece Intraocular Lenses, Model Visian® ICL, for surgical placement in the human eye.

Source page: https://510kreport.com/device/K101134
Methodology: https://510kreport.com/methodology