# K170183: Cetus system, Cetus probe

- Pathway: 510(k) (Traditional)
- Applicant: A.R.C Laser GmbH
- Decided: Sep 27, 2017 after 247 days
- Product code: HQE (Instrument, Vitreous Aspiration And Cutting, Ac-Powered)
- Device class: 2
- Regulation: 21 CFR 886.4150
- 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 K894278 (1989). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993154: Laser Photolysis System, Pharo Ophthalmic Surgery System, A.R.C. Laser Corp. (2000) Summary page 4.

## Indications for use
The Cetus Laser System is indicated for use in phacofragmentation of the cataractous crystalline lens.

Source page: https://510kreport.com/device/K170183
Methodology: https://510kreport.com/methodology