HQC — Unit, Phacofragmentation Class II

FDA Device Classification

Classification Details

Product Code
HQC
Device Class
Class II
Regulation Number
886.4670
Submission Type
Review Panel
OP
Medical Specialty
Ophthalmic
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K250501thisSystem SophiNovember 14, 2025
K243395carl zeiss meditec cataract technologyMICOR 700 with Auto I/AAugust 8, 2025
K242801carl zeiss meditec cataract technologyMICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-5062June 11, 2025
K240169bausch and lomb, incorporatedStellaris Elite vision enhancement system (BL11145, BL14455, BL15455)July 26, 2024
K233398oertli instrumenteFaros Surgical SystemJune 27, 2024
K233876alcon laboratoriesUNITY VCS (8065000296); UNITY CS (8065000297)June 21, 2024
K232084bausch and lombStellaris Elite vision enhancement systemFebruary 26, 2024
K233902alcon laboratoriesCenturion™ Vision System (Active Sentry™) (8065753057)January 10, 2024
K230858carl zeiss meditecQUATERA 700July 31, 2023
K214028carl zeiss meditec cataract technologyMICOR Lens Fragmentation SystemSeptember 9, 2022
K222236carl zeiss meditec cataract technologymiCOR System Lens Fragmentation SystemAugust 24, 2022
K213467d.o.r.c. dutch ophthalmic research center (international)EVA NEXUS Ophthalmic Surgical SystemJune 14, 2022
K212241carl zeiss meditecQUATERA 700April 19, 2022
K203060johnson and johnson surgical visionVERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack and AdvancedMarch 12, 2021
K200207carl zeiss meditec cataract technologyxPORT S Lens Fragmentation SystemOctober 15, 2020
K200584carl zeiss meditec cataract technologyxPORT 304 (miCOR) System Lens Fragmentation SystemJuly 31, 2020
K193376carl zeiss meditecVisalis V500, Visalis S500June 15, 2020
K192418raicoPhacoemulsification Needle (Tip) and Irrigation SleeveMay 27, 2020
K191650alcon researchLEGION SystemNovember 1, 2019
K190875d.o.r.c. dutch ophthalmic research center (international)EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DSeptember 25, 2019