FDA 510(k)

EVA NEXUS Ophthalmic Surgical System

K-Nummer: K213467 · 2022-06-14

AntragstellerD.O.R.C. Dutch Ophthalmic Research Center (International)

Entscheidungsdatum2022-06-14

ProduktcodeHQC

BeratungsausschussOP

EntscheidungSubstantially Equivalent

Produktübersicht

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.

Häufig gestellte Fragen

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.

Zugehörige klinische Studien

Zugehörige Einträge werden automatisch anhand von Namen, Produktcodes oder anderen Metadaten abgeglichen. Eine Übereinstimmung begründet kein verifiziertes klinisches, wissenschaftliches, unternehmerisches oder regulatorisches Verhältnis; prüfen Sie die verlinkten offiziellen Quellen.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Weitere Einträge mit D.O.R.C. Dutch Ophthalmic Research Center (International) als Antragsteller

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

Verwandte Geräte (Code: HQC)

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 Lomb K252052Stellaris Elite™ vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E)Bausch and Lomb, Incorporated K250501System SophiThis AG K243395MICOR 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

Offizielle Quelle

In der FDA-Datenbank anzeigen →

Daten aus der FDA Open API. Für die aktuellsten und verbindlichen Informationen konsultieren Sie bitte stets den offiziellen Datensatz.