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FDA 510(k)

Cetus system, Cetus probe

K-Number: K170183 · 2017-09-27

ApplicantA.R.C Laser GmbH
Decision Date2017-09-27
Product CodeHQE
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Cetus system, Cetus probe is a medical device manufactured by A.R.C Laser GmbH. It received FDA 510(k) clearance on 2017-09-27 under approval 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. It is manufactured by A.R.C Laser GmbH. The 510(k) number is K170183.

When was Cetus system, Cetus probe approved by the FDA?

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

What company makes Cetus system, Cetus probe?

Cetus system, Cetus probe is manufactured by A.R.C Laser GmbH.

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

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

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Official Source

View on FDA Database →

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

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