# K141079: Optimedica Catalys Precision Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Optimedica Corporation
- Decided: Sep 11, 2014 after 139 days
- Product code: OOE (Ophthalmic Femtosecond Laser)
- Device class: 2
- Regulation: 21 CFR 886.4390
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K913697 (1991). 57 ancestors in all.
8 later devices descend from it; 1 cites it directly.
0 of 66 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121091: Catalys Precision Laser System, Optimedica Corporation (2012) Summary page 4.

## Most influential descendants
- 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
- K182083: Catalys Precision Laser System (2018), 4 descendants of its own
- K200056: Catalys Precision Laser System (2020), 3 descendants of its own

## Recalls of this device
- 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
- Feb 20, 2015 · Class II · Z-1515-2015: Device may experience loss of suction during treatment resulting in scoring the cornea during lens fragmentation.
- Feb 20, 2015 · Class II · Z-1683-2015: Software anomaly on OptiMedica CATALYS System version 3.00.05 that may result in incorrect parameters provided for cataract incision surgeon templates and both eyes have the same parameters.

## Indications for use
The OptiMedica® Catalys® Precision Laser System is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens. Intended uses in cataract surgery include anterior capsulotomy, phacofragmentation, and the creation of single plane and multi-plane arc cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure.

Source page: https://510kreport.com/device/K141079
Methodology: https://510kreport.com/methodology