Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

EVA NEXUS Ophthalmic Surgical System

K-Number: K213467 · 2022-06-14

ApplicantD.O.R.C. Dutch Ophthalmic Research Center (International)
Decision Date2022-06-14
Product CodeHQC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

EVA NEXUS Ophthalmic Surgical System is the device name listed in this FDA 510(k) record. The listed applicant is D.O.R.C. Dutch Ophthalmic Research Center (International). It received FDA 510(k) clearance on 2022-06-14 under 510(k) number K213467. The device is classified under product code HQC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EVA NEXUS Ophthalmic Surgical System?

EVA NEXUS Ophthalmic Surgical System is a medical device that received FDA 510(k) clearance on 2022-06-14. The listed applicant is D.O.R.C. Dutch Ophthalmic Research Center (International). The 510(k) number is K213467.

When did EVA NEXUS Ophthalmic Surgical System receive FDA 510(k) clearance?

EVA NEXUS Ophthalmic Surgical System received FDA 510(k) clearance on 2022-06-14, under 510(k) number K213467.

Who is the listed applicant for EVA NEXUS Ophthalmic Surgical System?

The FDA 510(k) record lists D.O.R.C. Dutch Ophthalmic Research Center (International) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EVA NEXUS Ophthalmic Surgical System?

The FDA product code for EVA NEXUS Ophthalmic Surgical System is HQC.

Other records listing D.O.R.C. Dutch Ophthalmic Research Center (International) as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K190875EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC connector), EVA combined machine with laser (SMA connector)

Related Devices (Code: HQC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261264Stellaris Elite™ vision enhancement system; Posterior and Combined Procedure Pack(s): 23 ga. Posterior Elite™ Pack (SE5423); 23 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5423B); 25 ga. Posterior Elite™ Pack (SE5425); 25 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5425B); 27 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5427B); 23 ga. Bi-Blade™+ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5423BB+); 25 ga. Bi-Blade™+Bausch and LombK252052Stellaris Elite™ vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E)Bausch and Lomb, IncorporatedK250501System SophiThis AGK243395MICOR 700 with Auto I/ACarl Zeiss Meditec Cataract Technology, Inc.K242801MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621); MICOR 700 vitrector (FG-51185)Carl Zeiss Meditec Cataract Technology, Inc.K240169Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455)Bausch and Lomb, Incorporated

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.

↑