FDA Device Registration & Listing · Sinking Spring, PA, US · Registration 2523835
Normalized identity and public registration information from FDA records.
No proprietary names listed under this establishment.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| MSS | Folders And Injectors, Intraocular Lens (Iol) | Ophthalmic | Class 1 | 886.4300 | 2021-08-25 |
| MXY | Cannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl Acetal | Ophthalmic | Class 1 | 886.4350 | 2004-02-10 |
| HNY | Cystotome | Ophthalmic | Class 1 | 886.4350 | 1994-02-03 |
| HQC | Unit, Phacofragmentation | Ophthalmic | Class 2 | 886.4670 | 2019-11-13 |
| OGO | Intraocular Pressure Lowering Implant | Unknown | Class 3 | N/A | 2022-01-12 |
| OGO | Intraocular Pressure Lowering Implant | Unknown | Class 3 | N/A | 2016-08-05 |
| HQC | Unit, Phacofragmentation | Ophthalmic | Class 2 | 886.4670 | 2024-04-03 |
| HMX | Cannula, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 1994-02-03 |
| NGY | Cannula, Trocar, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2009-04-16 |
| KYB | Lens, Guide, Intraocular | Ophthalmic | Class 1 | 886.4300 | 2012-04-19 |
| HQR | Apparatus, Cautery, Radiofrequency, Ac-Powered | Ophthalmic | Class 2 | 886.4100 | 2012-04-19 |
| MLZ | Vitrectomy, Instrument Cutter | Ophthalmic | Class 2 | 886.4150 | 2012-04-19 |
| HQC | Unit, Phacofragmentation | Ophthalmic | Class 2 | 886.4670 | 2012-04-19 |
| HQC | Unit, Phacofragmentation | Ophthalmic | Class 2 | 886.4670 | 2015-11-06 |
| HQE | Instrument, Vitreous Aspiration And Cutting, Ac-Powered | Ophthalmic | Class 2 | 886.4150 | 2015-11-06 |
| HNN | Knife, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 1994-02-03 |
| MLZ | Vitrectomy, Instrument Cutter | Ophthalmic | Class 2 | 886.4150 | 2011-12-14 |
| HMX | Cannula, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2012-04-19 |
| HQE | Instrument, Vitreous Aspiration And Cutting, Ac-Powered | Ophthalmic | Class 2 | 886.4150 | 2012-04-19 |
| HQB | Photocoagulator And Accessories | Ophthalmic | Class 2 | 886.4690 | 2012-04-19 |
| NGY | Cannula, Trocar, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2012-04-19 |
| GAP | Suture, Nonabsorbable, Silk | General, Plastic Surgery | Class 2 | 878.5030 | 2023-01-09 |
| MPA | Endoilluminator | Gastroenterology, Urology | Class 2 | 876.1500 | 2024-12-06 |
| HOZ | Sponge, Ophthalmic | Ophthalmic | Class 2 | 886.4790 | 2007-12-19 |
| KYF | Implant, Eye Valve | Ophthalmic | Class 2 | 886.3920 | 2010-03-02 |
| HOZ | Sponge, Ophthalmic | Ophthalmic | Class 2 | 886.4790 | 2024-09-10 |
| OGO | Intraocular Pressure Lowering Implant | Unknown | Class 3 | N/A | 2017-12-18 |
| HNR | Forceps, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2002-04-15 |
No official correspondent registered.
No US Agent registered (Local establishment).
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3013497605 | Alcon Research, LLC | Sinking Spring, PA, US |
| 3003701944 | OPTONOL, LTD | NEVE ILAN Central, IL |
| 3016232028 | LUMITHERA, INC. | Fort Worth, TX, US |
| 3006186389 | CIBA VISION JOHOR SDN.BHD., | GELANG PATAH, JOHOR DARUL TAKZIM, MY |
| 3016075957 | IVANTIS, INC. | Irvine, CA, US |
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K191650 | Alcon Research, LLC | LEGION System | 2019-11-01 |
| K091915 | Lenstec, Inc. | FLUID ISOLATION DEVICE | 2009-10-27 |
| K830812 | Alphamedix, Inc. | ALPHAMEDIX I/A HAND-PIECE, 500-001 | 1983-06-08 |
| K133115 | Abbott Medical Optics, Inc. | COMPACT INTUITIV; SYSTEM, WIRELESS REMOTE CONTROL, FOUR-BUTTON FOOT PEDAL, SINGLE-USE FLUIDICS PACK | 2014-02-27 |
| K121721 | Abbott Medical Optics, Inc. | LAMINAR FLOW PHACO TIPS AND IRRIGATION SLEEVE (21G, REUSABLE) | 2012-10-15 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0095-2021 | Alcon Research, LLC | 2 | Alcon Custom-Pak Surgical Procedure Packs containing Cardinal Health" PROTEXIS" Latex Micro Surgical Gloves - Product Usage: used by ophthalmic surgeons in a variety of ophthalmic surgeries. |
| Z-0099-2024 | Alcon Research, LLC | 2 | Constellation Vision System, REF: 8065751150 |
| Z-0260-2024 | Alcon Research, LLC | 2 | Alcon Custom-Pak, Surgical Procedure Pack REF 14057-09, 45K W/DUOVISC CATARACT, N VIRGINIA EYE SURG CTR |
| Z-0354-2023 | Alcon Research, LLC | 2 | Alcon Custom Pak Surgical Procedure Pack |
| Z-1291-2023 | Alcon Research, LLC | 2 | Alcon Custom Pak Surgical Procedure Pack:
Pak Number & Pak Description:
17533-04 DR GROSS LPS LLC
18704-03 CATARACT SURGI CARE
18382-03 DR GEORGE ZAMBELLI BEAVER VALLEY ASC
8685-21 CATARACT PACK EYE SURGICAL CNTR OF AR
19451-02 DR ROESKE PACK INLAND VALLEY SURGERY CTR
19136-03 OCCULOPLASTIC WILMINGTON EYE
18401-03 MCGRAW SIGHTPATH MEDICAL
16032-05 MIDDLE TENNESSEE PACK SIGHTPATH MEDICAL
17570-05 CATARACT CENTURION FORT MADISON COMM HOS
19002-02 CATARACT BAPTIST HEALTH SURGERY CENTER
10560-14 CATARACT - NORTH CENTRAL 1 SIGHTPATH MED
16877-11 DR DAVID B LEACH CLEARVIEW SURGERY CENTE
19061-02 HOSLER UNIVERSITY SURGI CENTER
18911-02 MASON CATARACT THE ASC AT UNITED MEDICAL
17469-02 GENERAL CUSTOM PACK SHARP MEMORIAL HOSPI
18917-01 CATARACT 2 SURGERY CENTER OF THE TEMECUL
17115-06 DR SCZEPANSKI NORTH DAKOTA EYE CLINIC
17780-04 OPHTHALMIC TEXAS PRECISION SURGERY CENTE
2452-58 CATARACT BOLSA OUTPATIENT SURG CTR
19096-01 OPHTHALMIC EAST ALABAMA AMB SURGERY CENT
18023-04 OPHTHALMIC BRAINARD SURGERY CENTER
17039-13 EYE-Q COMPLETE CAT PAK VISION CARE SURG
5300-61 CATARACT WOODLAND MEM HOSP |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3012236936 | Johnson & Johnson Surgical Vision, Inc. | Irvine, CA, US |
| 1610287 | Alcon Research, LLC | Fort Worth, TX, US |
| 9681862 | MEDICEL AG | Altenrhein Sankt Gallen, CH |
| 1932180 | Bausch & Lomb Incorporated | Manchester, MO, US |
| 1313525 | Bausch & Lomb Incorporated | Rochester, NY, US |
2523835 when referencing this establishment in official correspondence.