# K063802: Lenstec LC Injection System

- Pathway: 510(k) (Traditional)
- Applicant: Lenstec, Inc.
- Decided: May 7, 2007 after 136 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). 8 ancestors in all.
10 later devices descend from it; 2 cite 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)
- K050638: Lenstec Intraocular Lens (Iol) Injection System for Tetraflex Intraocular Lenses, Lenstec, Inc. (2005) Summary page 2.
- K060533: Lenstec Intraocular Lens (Iol) Injection System, Lenstec, Inc. (2006) Summary page 2.

## Most influential descendants
- 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
- K181401: RxSight Insertion Device (2018), 4 descendants of its own
- K192926: RxSight Insertion Device (2020), 3 descendants of its own

## Indications for use
The Lenstec LC Injection System is intended for use in the implantation of STAAR Collamer Intraocular Lens model CC4204BF into the capsular bag following extracapsular extraction.

Source page: https://510kreport.com/device/K063802
Methodology: https://510kreport.com/methodology