# K082944: Crystalsert Crystalens Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Bausch & Lomb, Inc.
- Decided: Oct 16, 2008 after 14 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: 2 generations back to K914311 (1992). 2 ancestors in all.
3 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)
- K970727: Mport Foldable Lens Placement System, Chiron Vision Corp. (1997) Summary page 1.

## Most influential descendants
- K123736: Crystalsert Delivery System (2013), 2 descendants of its own
- 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 CrystalsertTM Crystalens® Delivery System is intended to be used to fold and deliver the Crystalens® (AT-50SE, AT-52SE, HD520 and HD500) accommodating intraocular lens into the capsular bag.

Source page: https://510kreport.com/device/K082944
Methodology: https://510kreport.com/methodology