# K121091: Catalys Precision Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Optimedica Corporation
- Decided: Aug 28, 2012 after 140 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: 11 generations back to K913697 (1991). 56 ancestors in all.
12 later devices descend from it; 2 cite 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)
- K113479: Optimedica Catalys Precision Laser System, Optimedica Corporation (2011) Summary page 1.

## Cited in the summary but kept off the family tree
- K1001626: LenSx Laser System (Alcon Corporation). Number could not be read

## Most influential descendants
- 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
- K182083: Catalys Precision Laser System (2018), 4 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
- Dec 20, 2013 · Class II · Z-0649-2014: Potential for unexpected heating of the transformer mounting bolt located within the system chassis and the subsequent melting of a non-slip computer shelf mat, which may manifest an odor and visible 

## Indications for use
The OptiMedica®)CatalysM 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/K121091
Methodology: https://510kreport.com/methodology