FDA.report

510(k) K250501

Device
System Sophi
Applicant
This AG
510(k) number
K250501
Product code
HQC
Decision
Substantially Equivalent (SESE)
Decision date
2025-11-14
Date received
2025-02-20
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
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Mr. Kai Kremnitzer
Address
Widnauerstrasse 1 Heerbrugg CH 9435 9435

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Related GUDID Devices

Primary DIBrandCompanyPublished
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07640179410755Cassette Peristaltic Sophi This AG2026-02-11
07640179410236SOPHI AThis AG2026-02-11
07630055243294Dynamic Phaco Set Sophi - 20G/30°This AG2026-02-11
07630055242884HighVac Phaco Set Sophi - 21G/30° 0.45This AG2026-02-11
07630055210883Phaco Set Sophi - 23G/CurvedThis AG2026-02-11
07630055210876Phaco Set Sophi - 21G/CurvedThis AG2026-02-11
07630055210869Phaco Set Sophi - 20G/CurvedThis AG2026-02-11
07630055210463Phaco Set Sophi - 23G/30°This AG2026-02-11
07630055210456Phaco Set Sophi - 21G/30°This AG2026-02-11
07630055210449Phaco Set Sophi - 20G/30°This AG2026-02-11
04251954900014Phaco Handpiece Sophi ECOThis AG2026-02-11
07640179410090SOPHIThis AG2026-02-10
07640179410007SOPHIThis AG2026-02-10

Other 510(k) Records For Product Code HQC

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
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
K203060VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack and Advanced Infusion Pack, VERITAS Swivel Handpiece, VERITAS Advanced Foot Pedal, VERITAS Remote ControlJohnson & Johnson Surgical Vision, Inc.2021-03-12