# K123736: Crystalsert Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Bausch & Lomb
- Decided: May 16, 2013 after 162 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: 3 generations back to K914311 (1992). 3 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082944: Crystalsert Crystalens Delivery System, Bausch & Lomb, Inc. (2008) Summary page 1.

## Most influential descendants
- K132593: Crystalsert Delivery System (2013), 1 descendant of its own
- K173480: Crystalsert Lens Delivery System (2017), 0 descendants of its own

## 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/K123736
Methodology: https://510kreport.com/methodology