# K173480: Crystalsert Lens Delivery System

- Pathway: 510(k) (Special)
- Applicant: Bausch & Lomb, Inc.
- Decided: Dec 11, 2017 after 28 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 K914311 (1992). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132593: Crystalsert Delivery System, Bausch & Lomb (2013) Summary page 4.

## Indications for use
The Crystalsert Delivery System is intended to be used to fold and deliver the Crystalens accommodating intraocular lens and other intraocular lenses identifying the Crystalsert Delivery System in their approved labeling.

Source page: https://510kreport.com/device/K173480
Methodology: https://510kreport.com/methodology