FDA 510(k)

Cetus system, Cetus probe

K-Number: K170183 · 2017-09-27

Decision Date2017-09-27

Product CodeHQE

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

Cetus system, Cetus probe is the device name listed in this FDA 510(k) record. The listed applicant is A.R.C Laser GmbH. It received FDA 510(k) clearance on 2017-09-27 under 510(k) number K170183. The device is classified under product code HQE. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cetus system, Cetus probe?

Cetus system, Cetus probe is a medical device that received FDA 510(k) clearance on 2017-09-27. The listed applicant is A.R.C Laser GmbH. The 510(k) number is K170183.

When did Cetus system, Cetus probe receive FDA 510(k) clearance?

Cetus system, Cetus probe received FDA 510(k) clearance on 2017-09-27, under 510(k) number K170183.

Who is the listed applicant for Cetus system, Cetus probe?

The FDA 510(k) record lists A.R.C Laser GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cetus system, Cetus probe?

The FDA product code for Cetus system, Cetus probe is HQE.

Other records listing A.R.C Laser GmbH as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K220531FOX 810, FOX 980 K192272Wolf445nm K161403A.R.C. Laser Surgical Fibers and Probes

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.