The following data is part of a premarket notification filed by A.r.c. Laser Gmbh with the FDA for Cetus System, Cetus Probe.
| Device ID | K170183 |
| 510k Number | K170183 |
| Device Name: | Cetus System, Cetus Probe |
| Classification | Instrument, Vitreous Aspiration And Cutting, Ac-powered |
| Applicant | A.R.C. Laser GmbH Bessemer St. 14 Nurnberg, DE 90411 |
| Contact | Angela Thyzel |
| Correspondent | Angela Thyzel A.R.C. Laser GmbH Bessemer St. 14 Nurnberg, DE 90411 |
| Product Code | HQE |
| CFR Regulation Number | 886.4150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-23 |
| Decision Date | 2017-09-27 |
| Summary: | summary |