Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
HQC — Predicate Candidate Screening
316 FDA 510(k) clearances under this product code; the 50 most recent screened below.
88 daysmedian FDA review time
240 days90th percentile
316clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261264 | Stellaris Elite™ vision enhancement system; Posterior and Co | Bausch and Lomb | 2026-05-15 | 29 | 0 |
| K252052 | Stellaris Elite™ vision enhancement system (BL11145, BL14455 | Bausch and Lomb, Incorporated | 2026-03-25 | 267 | 0 |
| K250501 | System Sophi | This AG | 2025-11-14 | 267 | 0 |
| K243395 | MICOR 700 with Auto I/A | Carl Zeiss Meditec Cataract Technology, Inc. | 2025-08-08 | 281 | 0 |
| K242801 | MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 70 | Carl Zeiss Meditec Cataract Technology, Inc. | 2025-06-11 | 267 | 0 |
| K240169 | Stellaris Elite vision enhancement system (BL11145, BL14455, | Bausch and Lomb, Incorporated | 2024-07-26 | 186 | 0 |
| K233398 | Faros Surgical System | Oertli Instrumente AG | 2024-06-27 | 268 | 0 |
| K233876 | UNITY VCS (8065000296); UNITY CS (8065000297) | Alcon Laboratories, Inc. | 2024-06-21 | 197 | 2 |
| K232084 | Stellaris Elite vision enhancement system | Bausch and Lomb | 2024-02-26 | 228 | 0 |
| K233902 | Centurion™ Vision System (Active Sentry™) (8065753057) | Alcon Laboratories, Inc. | 2024-01-10 | 30 | 0 |
| K230858 | QUATERA 700 | Carl Zeiss Meditec, AG | 2023-07-31 | 124 | 0 |
| K214028 | MICOR Lens Fragmentation System | Carl Zeiss Meditec Cataract Technology, Inc. | 2022-09-09 | 261 | 0 |
| K222236 | miCOR System Lens Fragmentation System | Carl Zeiss Meditec Cataract Technology, Inc. | 2022-08-24 | 29 | 0 |
| K213467 | EVA NEXUS Ophthalmic Surgical System | D.O.R.C. Dutch Ophthalmic Research Center (International) | 2022-06-14 | 229 | 6 |
| K212241 | QUATERA 700 | Carl Zeiss Meditec, AG | 2022-04-19 | 274 | 0 |
| K203060 | VERITAS Phacoemulsification Console, VERITAS Advanced Fluidi | Johnson & Johnson Surgical Vision, Inc. | 2021-03-12 | 155 | 3 |
| K200207 | xPORT S Lens Fragmentation System | Carl Zeiss Meditec Cataract Technology, Inc. | 2020-10-15 | 261 | 0 |
| K200584 | xPORT 304 (miCOR) System Lens Fragmentation System | Carl Zeiss Meditec Cataract Technology, Inc. | 2020-07-31 | 147 | 0 |
| K193376 | Visalis V500, Visalis S500 | Carl Zeiss Meditec, AG | 2020-06-15 | 193 | 0 |
| K192418 | Phacoemulsification Needle (Tip) and Irrigation Sleeve | Raico, LLC | 2020-05-27 | 266 | 0 |
| K191650 | LEGION System | Alcon Research, LLC | 2019-11-01 | 134 | 1 |
| K190875 | EVA, anterior machine, EVA, combined machine, EVA combined m | D.O.R.C. Dutch Ophthalmic Research Center (International) | 2019-09-25 | 174 | 0 |
| K191933 | COMPACT INTUITIV System, COMPACT INTUITIV Wireless Remote Co | Johnson & Johnson Surgical Vision, Inc. | 2019-08-16 | 28 | 0 |
| K191024 | xPORT Lens Fragmentation System | Carl Zeiss Meditec Cataract Technology, Inc. | 2019-08-13 | 117 | 0 |
| K170052 | Stellaris Elite vision enhancement system | Bausch+Lomb | 2017-04-19 | 104 | 0 |
| K161794 | CENTURION Vision System (Active SentryTM) | Alcon Research, Ltd. | 2017-04-14 | 288 | 0 |
| K162342 | Stellaris Elite Vision Enhancement System | Bausch+Lomb | 2017-03-24 | 214 | 0 |
| K160236 | Dual Pump Pack | Abbott Medical Optics, Inc. | 2016-04-27 | 86 | 1 |
| K151636 | AMO WHITESTAR Signature Pro Phacoemulsification System, WHIT | Abbott Medical Optics, Inc. | 2015-10-19 | 124 | 0 |
| K151783 | COMPACT INTUITIV Multiple-Use Pack | Abbott Medical Optics, Inc. | 2015-09-02 | 63 | 0 |
| K142877 | EVA,anterior machine, EVA, combined machine, EVA combined ma | Dutch Ophthalmic Research Center International BV | 2015-03-13 | 163 | 0 |
| K133562 | CATARHEX 3 | Oertli Instrumente AG | 2014-08-12 | 265 | 0 |
| K133486 | STELLARIS PC VISION ENHANCEMENT SYSTEM | Bausch & Lomb | 2014-03-12 | 119 | 3 |
| K133115 | COMPACT INTUITIV; SYSTEM, WIRELESS REMOTE CONTROL, FOUR-BUTT | Abbott Medical Optics, Inc. | 2014-02-27 | 150 | 1 |
| K133242 | STELLARIS VISION ENHANCEMENT SYSTEM | Bausch & Lomb | 2014-02-14 | 116 | 0 |
| K121555 | CENTURION VISION SYSTEM | Alcon Laboratories, Inc. | 2012-12-21 | 210 | 4 |
| K122829 | LENSAR LASER SYSTEM - FS 3D FOR CORNEAL INCISIONS | Lensar, Inc. | 2012-12-03 | 77 | 0 |
| K121721 | LAMINAR FLOW PHACO TIPS AND IRRIGATION SLEEVE (21G, REUSABLE | Abbott Medical Optics, Inc. | 2012-10-15 | 125 | 1 |
| K120732 | LENSSX LASER SYSTEM | Alcon Lensx, Inc. | 2012-09-06 | 181 | 0 |
| K120912 | INFINITI(R) VISION SYSTEM | Alcon Manufacturing, Ltd. | 2012-06-15 | 81 | 1 |
| K111446 | SOVEREIGN COMPACT PHACOEMULSIFICATION SYSTEM | Abbott Medical Optics, Inc. | 2011-12-21 | 211 | 1 |
| K112425 | INFINITI VISION SYSTEM EVERGREEN II AUTOSERT IOL INJECTOR HA | Alcon Manufacturing, Ltd. | 2011-11-21 | 90 | 0 |
| K111882 | LAMINAR FLOW PHACO TIPS | Abbott Medical Optics, Inc. | 2011-11-07 | 129 | 0 |
| K111697 | AMO WHITESTAR SIGNATURE PHACOEMULSIFICATION SYSTEM | Abbott Medical Optics, Inc. | 2011-09-27 | 102 | 0 |
| K103023 | UNIT, PHACOFRAGMENTATION | Abbott Medical Optics, Inc. | 2011-06-01 | 232 | 0 |
| K101285 | CONSTELLATION VISION SYSTEM | Alcon Manufacturing, Ltd. | 2010-11-12 | 189 | 1 |
| K101325 | STELLARIS PC VISION ENHANCEMENT SYSTEM | Bausch & Lomb, Inc. | 2010-08-17 | 97 | 1 |
| K093210 | AQUALASE CAPSULE WASH TIP | Alcon Manufacturing, Ltd. | 2010-03-04 | 142 | 0 |
| K091915 | FLUID ISOLATION DEVICE | Lenstec, Inc. | 2009-10-27 | 119 | 0 |
| K091777 | ALCON ULTRACHOPPER | Alcon Research, Ltd. | 2009-10-20 | 125 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda