K170183 is an FDA 510(k) clearance for the Cetus system, Cetus probe. This device is classified as 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 FDA review panel. Regulated under 21 CFR 886.4150.
| 510(k) Number | K170183 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| Product Code | HQE - Instrument, Vitreous Aspiration And Cutting, Ac-powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.4150 |