FDA Product Code
FDA Product Code HQC — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Ophthalmic
- 21 CFR Citation
- 886.4670
510(k) Clearances — 316 records · page 1 of 4
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261264 | Stellaris 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 | 2026-05-15 | Special | PDF ↗ |
| K252052 | Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E) | Bausch and Lomb, Incorporated | 2026-03-25 | Traditional | PDF ↗ |
| K250501 | System Sophi | This AG | 2025-11-14 | Traditional | PDF ↗ |
| K243395 | MICOR 700 with Auto I/A | Carl Zeiss Meditec Cataract Technology, Inc. | 2025-08-08 | Traditional | PDF ↗ |
| K242801 | MICOR 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 | Traditional | PDF ↗ |
| K240169 | Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455) | Bausch and Lomb, Incorporated | 2024-07-26 | Traditional | PDF ↗ |
| K233398 | Faros Surgical System | Oertli Instrumente AG | 2024-06-27 | Traditional | PDF ↗ |
| K233876 | UNITY VCS (8065000296); UNITY CS (8065000297) | Alcon Laboratories, Inc. | 2024-06-21 | Traditional | PDF ↗ |
| K232084 | Stellaris Elite vision enhancement system | Bausch and Lomb | 2024-02-26 | Traditional | PDF ↗ |
| K233902 | Centurion Vision System (Active Sentry) (8065753057) | Alcon Laboratories, Inc. | 2024-01-10 | Special | PDF ↗ |
| K230858 | QUATERA 700 | Carl Zeiss Meditec, AG | 2023-07-31 | Traditional | PDF ↗ |
| K214028 | MICOR Lens Fragmentation System | Carl Zeiss Meditec Cataract Technology, Inc. | 2022-09-09 | Traditional | PDF ↗ |
| K222236 | miCOR System Lens Fragmentation System | Carl Zeiss Meditec Cataract Technology, Inc. | 2022-08-24 | Special | PDF ↗ |
| K213467 | EVA NEXUS Ophthalmic Surgical System | D.O.R.C. Dutch Ophthalmic Research Center (International) | 2022-06-14 | Traditional | PDF ↗ |
| K212241 | QUATERA 700 | Carl Zeiss Meditec, AG | 2022-04-19 | Traditional | PDF ↗ |
| K203060 | VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack and Advanced Infusion Pack, VERITAS Swivel Handpiece, VERITAS Advanced Foot Pedal, VERITAS Remote Control | Johnson & Johnson Surgical Vision, Inc. | 2021-03-12 | Traditional | PDF ↗ |
| K200207 | xPORT S Lens Fragmentation System | Carl Zeiss Meditec Cataract Technology, Inc. | 2020-10-15 | Traditional | PDF ↗ |
| K200584 | xPORT 304 (miCOR) System Lens Fragmentation System | Carl Zeiss Meditec Cataract Technology, Inc. | 2020-07-31 | Traditional | PDF ↗ |
| K193376 | Visalis V500, Visalis S500 | Carl Zeiss Meditec, AG | 2020-06-15 | Traditional | PDF ↗ |
| K192418 | Phacoemulsification Needle (Tip) and Irrigation Sleeve | Raico, LLC | 2020-05-27 | Traditional | PDF ↗ |
| K191650 | LEGION System | Alcon Research, LLC | 2019-11-01 | Traditional | PDF ↗ |
| K190875 | EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC connector), EVA combined machine with laser (SMA connector) | D.O.R.C. Dutch Ophthalmic Research Center (International) | 2019-09-25 | Traditional | PDF ↗ |
| K191933 | COMPACT INTUITIV System, COMPACT INTUITIV Wireless Remote Control, COMPACT INTUITIV Four-Button Foot Pedal, COMPACT INTUITIV Closed-Toe Foot Pedal | Johnson & Johnson Surgical Vision, Inc. | 2019-08-16 | Special | PDF ↗ |
| K191024 | xPORT Lens Fragmentation System | Carl Zeiss Meditec Cataract Technology, Inc. | 2019-08-13 | Traditional | PDF ↗ |
| K170052 | Stellaris Elite vision enhancement system | Bausch+Lomb | 2017-04-19 | Traditional | PDF ↗ |
| K161794 | CENTURION Vision System (Active SentryTM) | Alcon Research, Ltd. | 2017-04-14 | Traditional | PDF ↗ |
| K162342 | Stellaris Elite Vision Enhancement System | Bausch+Lomb | 2017-03-24 | Traditional | PDF ↗ |
| K160236 | Dual Pump Pack | Abbott Medical Optics, Inc. | 2016-04-27 | Abbreviated | PDF ↗ |
| K151636 | AMO WHITESTAR Signature Pro Phacoemulsification System, WHITESTAR Signature Pro Advance Linear (Four-Button) Foot Pedal, WHITESTAR Signature Pro (Wireless) Remote Control | Abbott Medical Optics, Inc. | 2015-10-19 | Traditional | PDF ↗ |
| K151783 | COMPACT INTUITIV Multiple-Use Pack | Abbott Medical Optics, Inc. | 2015-09-02 | Abbreviated | PDF ↗ |
| K142877 | EVA,anterior machine, EVA, combined machine, EVA combined machine with laser(DORC connector), EVA combined machine with laser SMA connector) | Dutch Ophthalmic Research Center International BV | 2015-03-13 | Traditional | PDF ↗ |
| K133562 | CATARHEX 3 | Oertli Instrumente AG | 2014-08-12 | Traditional | PDF ↗ |
| K133486 | STELLARIS PC VISION ENHANCEMENT SYSTEM | Bausch & Lomb | 2014-03-12 | Traditional | PDF ↗ |
| K133115 | COMPACT INTUITIV; SYSTEM, WIRELESS REMOTE CONTROL, FOUR-BUTTON FOOT PEDAL, SINGLE-USE FLUIDICS PACK | Abbott Medical Optics, Inc. | 2014-02-27 | Abbreviated | PDF ↗ |
| K133242 | STELLARIS VISION ENHANCEMENT SYSTEM | Bausch & Lomb | 2014-02-14 | Special | PDF ↗ |
| K121555 | CENTURION VISION SYSTEM | Alcon Laboratories, Inc. | 2012-12-21 | Traditional | PDF ↗ |
| K122829 | LENSAR LASER SYSTEM - FS 3D FOR CORNEAL INCISIONS | Lensar, Inc. | 2012-12-03 | Traditional | PDF ↗ |
| K121721 | LAMINAR FLOW PHACO TIPS AND IRRIGATION SLEEVE (21G, REUSABLE) | Abbott Medical Optics, Inc. | 2012-10-15 | Traditional | PDF ↗ |
| K120732 | LENSSX LASER SYSTEM | Alcon Lensx, Inc. | 2012-09-06 | Traditional | PDF ↗ |
| K120912 | INFINITI(R) VISION SYSTEM | Alcon Manufacturing, Ltd. | 2012-06-15 | Traditional | PDF ↗ |
| K111446 | SOVEREIGN COMPACT PHACOEMULSIFICATION SYSTEM | Abbott Medical Optics, Inc. | 2011-12-21 | Traditional | PDF ↗ |
| K112425 | INFINITI VISION SYSTEM EVERGREEN II AUTOSERT IOL INJECTOR HANDPIECE | Alcon Manufacturing, Ltd. | 2011-11-21 | Traditional | PDF ↗ |
| K111882 | LAMINAR FLOW PHACO TIPS | Abbott Medical Optics, Inc. | 2011-11-07 | Abbreviated | PDF ↗ |
| K111697 | AMO WHITESTAR SIGNATURE PHACOEMULSIFICATION SYSTEM | Abbott Medical Optics, Inc. | 2011-09-27 | Abbreviated | PDF ↗ |
| K103023 | UNIT, PHACOFRAGMENTATION | Abbott Medical Optics, Inc. | 2011-06-01 | Abbreviated | PDF ↗ |
| K101285 | CONSTELLATION VISION SYSTEM | Alcon Manufacturing, Ltd. | 2010-11-12 | Traditional | PDF ↗ |
| K101325 | STELLARIS PC VISION ENHANCEMENT SYSTEM | Bausch & Lomb, Inc. | 2010-08-17 | Traditional | PDF ↗ |
| K093210 | AQUALASE CAPSULE WASH TIP | Alcon Manufacturing, Ltd. | 2010-03-04 | Traditional | PDF ↗ |
| K091915 | FLUID ISOLATION DEVICE | Lenstec, Inc. | 2009-10-27 | Traditional | PDF ↗ |
| K091777 | ALCON ULTRACHOPPER | Alcon Research, Ltd. | 2009-10-20 | Traditional | PDF ↗ |
| K082845 | INFINITI VISION SYSTEM WITH OZIL IP | Alcon Research, Ltd. | 2009-02-12 | Traditional | PDF ↗ |
| K081877 | ASSOCIATE 2500 DUAL AND COMPACT SYSTEMS | Dutch Ophthalmic Research Center International BV | 2009-01-05 | Traditional | PDF ↗ |
| K082473 | BAUSCH & LOMB STELLARIS MICROSURGICAL SYSTEM | Bausch & Lomb, Inc. | 2009-01-05 | Abbreviated | PDF ↗ |
| K080803 | VISUAL PHACOEMULSIFICATION SYSTEM, MODEL 551 | American Optisurgical, Inc. | 2008-09-22 | Traditional | PDF ↗ |
| K082132 | BAUSCH & LOMB D4600A AIR EXCHANGE LINE PACK | Bausch & Lomb, Inc. | 2008-08-28 | Special | PDF ↗ |
| K063583 | ALCON VISION SYSTEM | Alcon | 2008-05-09 | Traditional | PDF ↗ |
| K073023 | STERILS SINGLE-USE I/A HANDPIECES | Bausch & Lomb, Inc. | 2008-03-12 | Special | PDF ↗ |
| K063331 | BAUSCH & LOMB NGX MICROSURGICAL SYSTEM | Bausch & Lomb, Inc. | 2006-12-19 | Abbreviated | PDF ↗ |
| K060366 | THE AMO OPHTHALMIC SURGICAL SYSTEM | Advanced Medical Optics, Inc. | 2006-04-07 | Abbreviated | PDF ↗ |
| K051186 | MICROPULSE PHACOEMULSIFICATION SYSTEM | Trillium Medical, Inc. | 2005-08-18 | Abbreviated | PDF ↗ |
| K050648 | SOVEREIGN HIGH VACUUM PACK, SOVEREIGN COMPACT HIGH VACUUM PACK | Advanced Medical Optics, Inc. | 2005-04-05 | Traditional | PDF ↗ |
| K041998 | PHACO CHOP NEEDLES | Bausch & Lomb, Inc. | 2004-08-16 | Special | PDF ↗ |
| K033653 | VENTURI PHACO PACK | Bausch & Lomb, Inc. | 2003-12-17 | Special | PDF ↗ |
| K030957 | PERFECT CAPSULE | Milvella Pty. , Ltd. | 2003-08-20 | Traditional | PDF ↗ |
| K031404 | DIGNITY OPHTHALMIC SURGICAL SYSTEM | Phacor Inc., A Santen Company | 2003-05-22 | Traditional | PDF ↗ |
| K022833 | BENJAMIN ENVOY PHACO HANDPIECE | Benjamin Biomedical, Inc. | 2002-09-09 | Traditional | PDF ↗ |
| K020527 | HORIZON PHACOEMULSIFICATION SYSTEM, MODEL HZN-2030 | American Optisurgical, Inc. | 2002-07-09 | Traditional | PDF ↗ |
| K021566 | INFINITI | Alcon Laboratories, Inc. | 2002-07-02 | Traditional | PDF ↗ |
| K020734 | SURGE-FREE ASPIRATION ADAPTER | Staar Surgical Co. | 2002-05-16 | Traditional | PDF ↗ |
| K003638 | MOJAVE CATARACT EXTRACTION SYSTEM | Allergan, Inc. | 2001-02-13 | Abbreviated | PDF ↗ |
| K003512 | LASER PACK I, LASER PACK II, PHACO PACK I, PHACO PACK II | A.R.C. Laser AG | 2001-02-08 | Traditional | PDF ↗ |
| K002932 | PHACOGARD | Syntec, Inc. | 2001-01-04 | Traditional | PDF ↗ |
| K002031 | PHACOFRAGMENTATION SYSTEM MEGATRON | Asclepion-Meditec AG | 2000-12-27 | Traditional | PDF ↗ |
| K002986 | A.R.C. LOW BUBBLE TURBO NEEDLE, MODEL WE0106.5 | A.R.C. Laser AG | 2000-11-29 | Traditional | PDF ↗ |
| K002812 | IRIS RETRACTING PHACOEMULSIFICATION SLEEVE | Michael Reynard, M.D. | 2000-11-08 | Traditional | PDF ↗ |
| K991852 | OCUSYSTEM ART ADVANTAGE, MODEL 995 | Surgical Design Corp. | 1999-07-07 | Traditional | PDF ↗ |
| K984143 | FIBRA-SONICS PHACO III OR IIIP FRAGMENTATION SYSTEM | Fibra Sonics, Inc. | 1999-02-16 | Traditional | PDF ↗ |
| K981989 | THE WAVE DIGITAL PHACO SYSTEM | Circuit Tree | 1998-08-25 | Traditional | PDF ↗ |
| K981103 | TURBOSONICS LIMITED REUSE ULTRASONIC TIP | Alcon Laboratories | 1998-06-23 | Traditional | PDF ↗ |
| K981109 | QUITETIP | Paradigm Medical Industries, Inc. | 1998-06-09 | Traditional | PDF ↗ |
| K980480 | SYNTEC VITMAN | Syntec, Inc. | 1998-05-04 | Traditional | PDF ↗ |
| K974469 | MENTOR PHACOEMULSIFICATION SISTEM REMOTE CONTROL | Mentor Corp. | 1998-02-24 | Traditional | PDF ↗ |
| K980085 | PHACO COMMANDER | Scieran Technologies, Inc. | 1998-02-24 | Traditional | PDF ↗ |
| K974719 | PHACOPAK | Paradigm Medical Industries, Inc. | 1998-01-20 | Traditional | PDF ↗ |
| K973749 | FRAG COMMANDER | Scieran Technologies, Inc. | 1997-12-08 | Traditional | PDF ↗ |
| K972063 | WHITTINGHAM ULTRACLEAN PHACO HANDPIECE | William F. Whittingham | 1997-11-25 | Traditional | PDF ↗ |
| K972252 | VISTA UNIVERSAL HANDPIECE | Odyssey Technologies, Inc. | 1997-07-29 | Traditional | PDF ↗ |
| K972253 | P3 UNIVERSAL PHACO HANDPIECE | Odyssey Technologies, Inc. | 1997-07-29 | Traditional | PDF ↗ |
| K971795 | AUTOMATED CHAMBER MAINTENANCE MODULE | Paradigm Medical Industries, Inc. | 1997-07-14 | Traditional | PDF ↗ |
| K971750 | WELCH ALLYN PHACO ILLUMINATOR | Welch Allyn, Inc. | 1997-06-30 | Traditional | PDF ↗ |
| K971439 | STORZ MICROFLOW AND STORZ STANDARD PHACOEMULSIFICATION NEEDLES | Storz Instrument Co. | 1997-06-17 | Traditional | PDF ↗ |
| K971186 | AMO DIPLOMAX/OPSYS CONSOLE | Allergan, Inc. | 1997-06-13 | Traditional | PDF ↗ |
| K971064 | BAYERS BIMANUAL I/A HANDPIECES | Visioncare Devices, Inc. | 1997-06-09 | Traditional | PDF ↗ |
| K965127 | DGH MODEL 9000 | Dgh Technology, Inc. | 1997-03-17 | Traditional | PDF ↗ |
| K964018 | PHACOILLUMINATOR - FIBEROPTIC SLEEVE | Michael Reynard, M.D. | 1997-02-26 | Traditional | PDF ↗ |
| K960287 | HANDPIECE FOR NIDEK CV-12000 PHACO SYSTEM | Nidek, Inc. | 1996-11-05 | Traditional | PDF ↗ |
| K960811 | PHACOSCOPE | Saint John'S Plaza Medical Group | 1996-10-02 | Traditional | PDF ↗ |
| K960024 | STORZ D7120 PHACO HANDPIECE MAINTENANCE KIT & STORZ D7125 PHACO HANDPIECE NEEDLE WRENCH | Storz Instrument Co. | 1996-09-20 | Traditional | PDF ↗ |
| K962402 | AMO PRESTIGE DAY PACK (ALLERGAN, INC.) | Allergan, Inc. | 1996-09-19 | Traditional | PDF ↗ |
| K960003 | STORZ D7116 MICROVIT VITRECTOMY CUTTER EXTENSION | Storz Instrument Co. | 1996-08-29 | Traditional | PDF ↗ |
Product code HQC · Class II · Ophthalmic. Data: openFDA.