# K103495: Asico Softip Injector System

- Pathway: 510(k) (Traditional)
- Applicant: Asico, LLC
- Decided: Jun 29, 2011 after 212 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: 6 generations back to K930320 (1994). 11 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040837: Multiject Injector and Microglide Cartridge, Medicel AG (2004) Summary page 1.
- K092023: Naviject SUB2-1P, Model: LP604430, Medicel AG (2009) Summary page 1.
- K063802: Lenstec LC Injection System, Lenstec, Inc. (2007) Summary page 1.

## Most influential descendants
- K142056: Lioli Iol Delivery System (2015), 6 descendants of its own
- K172228: pioli IOL Delivery System (2017), 5 descendants of its own
- K181401: RxSight Insertion Device (2018), 4 descendants of its own
- K192926: RxSight Insertion Device (2020), 3 descendants of its own
- K231466: RxSight Insertion Device (2023), 2 descendants of its own

## Indications for use
The ASICO SofTip Injector system is a sterile, single use device intended to insert a foldable intraocular lens through a surgical procedure in a Human eye. The system provides a tubular pathway through a incision, allowing the delivery of a IOL into the Human eye. This is indicated for the insertion only of models of intraocular lens that allow use of this injector in their approved labelling

Source page: https://510kreport.com/device/K103495
Methodology: https://510kreport.com/methodology