# K140362: Katalyst Revolver Laser Probes, Katalyst Revolver Illuminated Laser Probes, Katalyst Revolver Illuminated Probes

- Pathway: 510(k) (Traditional)
- Applicant: Katalyst Surgical, LLC
- Decided: Sep 15, 2014 after 215 days
- Product code: HQF (Laser, Ophthalmic)
- Device class: 2
- Regulation: 21 CFR 886.4390
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K870942 (1987). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121187: Katalyst Laser Probes, Katalyst Illuminated Laser Probes, Katalyst Surgical, LLC (2012) Summary page 5.

## Indications for use
Revolver Laser Probes, Revolver Illuminated Laser Probes & Revolver Illuminated Probes are intended for use in vitreoretinal surgery to perform endo-ocular laser photocoagulation treatments. The Revolver Laser Probes can only be used with a medical laser at operating wavelengths of 500nm to 900nm. The Revolver assemblies containing illumination should only be used with the light wavelength range of 425nm to 700nm.

Source page: https://510kreport.com/device/K140362
Methodology: https://510kreport.com/methodology