# K092023: Naviject SUB2-1P, Model: LP604430

- Pathway: 510(k) (Special)
- Applicant: Medicel AG
- Decided: Jul 28, 2009 after 22 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: 4 generations back to K930320 (1994). 6 ancestors in all.
18 later devices descend from it; 3 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070669: Iol Injector Set, Medicel AG (2007) Summary page 1.

## Most influential descendants
- K113852: Bausch & Lomb Iol Injector (2012), 12 descendants of its own
- K131958: Bausch & Lomb Injector System (2014), 9 descendants of its own
- K103495: Asico Softip Injector System (2011), 7 descendants of its own
- K142056: Lioli Iol Delivery System (2015), 6 descendants of its own
- K172228: pioli IOL Delivery System (2017), 5 descendants of its own

## Indications for use
The Naviject Sub2-1 P IOL Injector and Cartridge Set for intraocular lenses is indicated for the insertion only of models of intraocular lenses that allow use of this injector in their approved labeling.

Source page: https://510kreport.com/device/K092023
Methodology: https://510kreport.com/methodology