FDA.reportPublic FDA data

510(k) K190875

Device
EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC connector), EVA combined machine with laser (SMA connector)
Applicant
D.O.R.C. Dutch Ophthalmic Research Center (International)
510(k) number
K190875
Product code
HQC
Decision
Substantially Equivalent (SESE)
Decision date
2019-09-25
Date received
2019-04-04
Regulation
886.4670
Classification name
Unit, Phacofragmentation
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Linda Van Leeuwen
Address
B.V. Scheijdelveweg 2 Zuidland NL 3214 VN 3214 VN

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code HQC#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
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 Lomb2026-05-15
K252052Stellaris Elite™ vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E)Bausch and Lomb, Incorporated2026-03-25
K250501System SophiThis AG2025-11-14
K243395MICOR 700 with Auto I/ACarl Zeiss Meditec Cataract Technology, Inc.2025-08-08
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.2025-06-11
K240169Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455)Bausch and Lomb, Incorporated2024-07-26
K233398Faros Surgical SystemOertli Instrumente AG2024-06-27
K233876UNITY VCS (8065000296); UNITY CS (8065000297)Alcon Laboratories, Inc.2024-06-21
K232084Stellaris Elite vision enhancement systemBausch and Lomb2024-02-26
K233902Centurion™ Vision System (Active Sentry™) (8065753057)Alcon Laboratories, Inc.2024-01-10
K230858QUATERA 700Carl Zeiss Meditec, AG2023-07-31
K214028MICOR Lens Fragmentation SystemCarl Zeiss Meditec Cataract Technology, Inc.2022-09-09
K222236miCOR System Lens Fragmentation SystemCarl Zeiss Meditec Cataract Technology, Inc.2022-08-24
K213467EVA NEXUS Ophthalmic Surgical SystemD.O.R.C. Dutch Ophthalmic Research Center (International)2022-06-14
K212241QUATERA 700Carl Zeiss Meditec, AG2022-04-19