Cetus system, Cetus probe— 510(k) K170183

Substantially Equivalent

A.R.C Laser GmbH

FDA 510(k) clearance K170183 for Cetus system, Cetus probe, Substantially Equivalent on 2017-09-27. Applicant: A.R.C Laser GmbH.

Clearance details

Applicant: A.R.C Laser GmbH
Product code: Code HQE
Advisory panel: Ophthalmic
Date received: 2017-01-23
Decision date: 2017-09-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nurnberg, DE

Download summary PDF View on FDA.gov ↗

Adverse events under product code HQE

product code HQE

Injury: 156
Malfunction: 565
Total: 721

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.