# K113479: Optimedica Catalys Precision Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Optimedica Corporation
- Decided: Dec 21, 2011 after 28 days
- Product code: OOE (Ophthalmic Femtosecond Laser)
- Device class: 2
- Regulation: 21 CFR 886.4390
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K913697 (1991). 55 ancestors in all.
13 later devices descend from it; 1 cites it directly.
0 of 69 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K094052: Lensx 550 Laser System. Model 550, Lensx Lasers, Inc. (2010) Summary page 1.

## Most influential descendants
- K121091: Catalys Precision Laser System (2012), 12 descendants of its own
- K141079: Optimedica Catalys Precision Laser System (2014), 8 descendants of its own
- K161455: Catalys Precision Laser System (2016), 7 descendants of its own
- K170322: Catalys Precision Laser System (2017), 6 descendants of its own
- K172002: Catalys Precision Laser System (2017), 5 descendants of its own

## Recalls of this device
- Oct 21, 2021 · Class II · Z-0444-2022: Aberrometer and precision laser systems are affected by a remote code execution vulnerability existing when the Microsoft Windows Print Spooler service is enabled, and improperly performs privileged f
- May 9, 2018 · Class II · Z-0066-2019: Software upgrade exhibits failures when executing Daily Alignment Verification (DAV), specifically, cuts on the plastic hemisphere during DAV do not match the intended cuts shown on the treatment over

## Indications for use
The OptiMedica CatalysTM Precision Laser System is indicated for anterior capsulotomy and laser phacofragmentation during cataract surgery. The anterior capsulotomy and phacofragmentation procedures may be performed either individually or consecutively during the same surgery.

Source page: https://510kreport.com/device/K113479
Methodology: https://510kreport.com/methodology