The following data is part of a premarket notification filed by D.o.r.c. Dutch Ophthalmic Research Center (international) with the FDA for Eva Nexus Ophthalmic Surgical System.
| Device ID | K213467 |
| 510k Number | K213467 |
| Device Name: | EVA NEXUS Ophthalmic Surgical System |
| Classification | Unit, Phacofragmentation |
| Applicant | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. Scheijdelveweg 2 Zuidland, NL 3214 VN |
| Contact | Linda Van Leeuwen |
| Correspondent | Linda Van Leeuwen D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. Scheijdelveweg 2 Zuidland, NL 3214 VN |
| Product Code | HQC |
| Subsequent Product Code | FMF |
| Subsequent Product Code | HQE |
| Subsequent Product Code | HQF |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-10-28 |
| Decision Date | 2022-06-14 |