# K161776: Lenstec LC Injection system

- Pathway: 510(k) (Traditional)
- Applicant: Lenstec, Inc.
- Decided: Nov 29, 2016 after 153 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: 7 generations back to K930320 (1994). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122848: Lenstec LC Injection System, Lenstec, Inc. (2013) Summary page 4.

## Indications for use
Lenstec’s LC Injection System is intended for use in the implantation of the Softec HD, Softec I, Softec HDO, Softec HDM and any approved IOL in which the labeling specifies use of this injector (s) to insert the lens into the capsular bag following extracapsular extraction.

Source page: https://510kreport.com/device/K161776
Methodology: https://510kreport.com/methodology