Cleared Traditional

Cetus system, Cetus probe

K170183 · A.R.C Laser GmbH · Ophthalmic
Sep 2017
Decision
247d
Days
Class 2
Risk

About This 510(k) Submission

K170183 is an FDA 510(k) clearance for the Cetus system, Cetus probe, a Instrument, Vitreous Aspiration And Cutting, Ac-powered (Class II — Special Controls, product code HQE), submitted by A.R.C Laser GmbH (Nurnberg, DE). The FDA issued a Cleared decision on September 27, 2017, 247 days after receiving the submission on January 23, 2017. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4150.

Submission Details

510(k) Number K170183 FDA.gov
FDA Decision Cleared SESE
Date Received January 23, 2017
Decision Date September 27, 2017
Days to Decision 247 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code HQE — Instrument, Vitreous Aspiration And Cutting, Ac-powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.4150

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