Product code KYB
- Device name
- Lens, Guide, Intraocular
- Medical specialty
- Ophthalmic
- Device class
- 1
- Regulation number
- 886.4300
- Review panel
- OP
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K152357 | MicroSTAAR Injector System Cartridges | STAAR Surgical Company | 2015-10-30 |
| K081382 | DUCKWORTH & KENT, LTD., IMPLANTATION SYSTEM, MODEL DK7786 | Duckworth & Kent, Ltd. | 2008-10-23 |
| K072985 | DUCKWORTH & KENT LTD INJECTOR, MODEL: DK7797-2 | Duckworth & Kent, Ltd. | 2008-06-20 |
| K070669 | IOL INJECTOR SET | Medicel AG | 2007-11-01 |
| K063155 | MONARCH III IOL DELIVERY SYSTEM | Alcon Manufacturing, Ltd. | 2007-03-27 |
| K063694 | AKREOS SINGLE USE INSERTION DEVICE, MODEL AI-28 | Bausch & Lomb, Inc. | 2007-03-07 |
| K032412 | RE-USEABLE MICROSTAAR INJECTOR, MSI-S | Staar Surgical Co. | 2004-06-10 |
| K022723 | MASTEL 1 FOLDER IMPLANTATION SYSTEM | Mastel Precision, Inc. | 2002-12-26 |
| K001157 | MONARCH II IOL DELIVERY SYSTEM | Alcon Research, Ltd. | 2000-06-27 |
| K983129 | DISPOSABLE MICROSTAAR INJECTOR (MODEL MSI-P1) | Staar Surgical Co. | 1998-12-04 |
| K981571 | MONARCH IOL DELIVERY SYSTEM | Alcon Laboratories | 1998-07-09 |
| K970033 | MONARCH IOL DELIVERY SYSTEM | Alcon Laboratories | 1997-04-23 |
| K965185 | ACRYPAK FOLDER | Alcon Laboratories | 1997-03-31 |
| K961242 | AMO PHACOFLEX II INTERSECTION SYSTEM | Allergan, Inc. | 1996-06-17 |
| K954600 | MICROSTAAR INJECTOR MODELS MSI-TD & MSI-PD (MODIFICATION) | Staar Surgical Co. | 1995-12-21 |
| K951292 | PASSPORT FOLDABLE LENS PLACEMENT SYSTEM | Chiron Vision Corp. | 1995-06-02 |
| K930628 | KLAAS IOL LENSFOLDER | Bova Intl. | 1995-02-07 |
| K940593 | DISPOSABLE MICROSTAAR INJECTOR | Staar Sugical | 1994-09-19 |
| K941603 | AMO PHACOFLEX INSERTER DISPOSABLE CARTRIDGE, AND HANDPIECE | Allergan Medical Optics | 1994-07-06 |
| K930320 | AMO PHACOFLEX INSERTER, FOLDABLE IOL INSERT INSTR | Allergan Medical Optics | 1994-04-07 |
| K903575 | CHIROFLEX FORCEPS | Chiron Ophthalmics | 1990-12-21 |
| K903574 | CHIROFLEX LENS MICROSERT | Chiron Ophthalmics | 1990-09-17 |
| K883489 | KRATZ NOVA SERT(TM) | Coopervision-Cilco | 1988-10-25 |
| K871440 | KRATZ NOVA-SERT | CooperVision, Inc. | 1987-05-07 |
| K870265 | KRATZ NOVA-SERT. SOFT INTRAOCULAR LENS INJECTOR | CooperVision, Inc. | 1987-02-20 |
| K861990 | SOFT LENS FOLDER | Staar Surgical Co. | 1986-06-17 |
| K861085 | ELASTIC LENS INJECTOR TM | Staar Surgical Co. | 1986-05-28 |
| K860148 | MAZZOCCO/FRENCHIK FOLDER | Staar Surgical Co. | 1986-03-21 |
| K854994 | BARTELL SMALL INCISION LENS GLIDE | Microtech, Inc. | 1986-02-04 |
| K854197 | IOSERT LENS IMPLANT INSTRUMENT | Chiron Vision Corp. | 1986-01-22 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07630055214935 | VISCOJECT 1.8 Injector Set | Medicel AG | 2026-04-28 |
| 07630055213853 | VISCOJECT 2.2 Injector Set | Medicel AG | 2026-04-24 |
| 00194613086435 | MSI Precision Specialty Instruments | Med Saver, Inc. | 2025-08-01 |
| 00194613123147 | MSI Precision Specialty Instruments | Med Saver, Inc. | 2025-03-21 |
| 00840311344796 | MicroStaar | STAAR SURGICAL COMPANY | 2023-06-15 |
| 05055313822295 | Duckworth & Kent | DUCKWORTH AND KENT LIMITED | 2022-08-31 |
| 05055313821632 | Duckworth & Kent | DUCKWORTH AND KENT LIMITED | 2022-08-31 |
| 05055313820901 | Duckworth & Kent | DUCKWORTH AND KENT LIMITED | 2022-08-31 |
| 05055313818922 | Duckworth & Kent | DUCKWORTH AND KENT LIMITED | 2022-08-31 |
| 05055313817222 | Duckworth & Kent | DUCKWORTH AND KENT LIMITED | 2022-08-31 |
| 00757770473946 | Bausch + Lomb | Bausch & Lomb Incorporated | 2022-02-25 |
| 00380659777738 | MONARCH® III | Alcon Laboratories, Inc. | 2020-08-19 |
| 10380659777575 | MONARCH® II | Alcon Laboratories, Inc. | 2020-05-20 |
| 00380659777578 | MONARCH® II | Alcon Laboratories, Inc. | 2020-05-20 |
| 00380659777585 | MONARCH® II | Alcon Laboratories, Inc. | 2020-05-20 |
| 00380659777639 | MONARCH® III | Alcon Laboratories, Inc. | 2020-05-20 |
| 00813465011135 | IOL Manipulator - Lester | HURRICANE MEDICAL INC | 2020-05-08 |
| 00813465011142 | IOL Manipulator - Sinskey | HURRICANE MEDICAL INC | 2020-05-08 |
| 00813465011166 | IOL Manipulator - Sinskey | HURRICANE MEDICAL INC | 2020-05-08 |
| 00813465011180 | Nucleus Chopper - Beckingsale | HURRICANE MEDICAL INC | 2020-05-08 |
| 00813465011173 | Nucleus Chopper - P. Koch | HURRICANE MEDICAL INC | 2020-05-08 |
| 00813465012071 | Surgical Glide | HURRICANE MEDICAL INC | 2020-05-05 |
| 00813465012101 | IOL Glide - Sheets | HURRICANE MEDICAL INC | 2020-05-05 |
| 05050474540323 | UNFOLDER PLATINUM 1 SERIES | JOHNSON & JOHNSON SURGICAL VISION, INC. | 2019-02-13 |
| 05050474534605 | ONE SERIES ULTRA | JOHNSON & JOHNSON SURGICAL VISION, INC. | 2019-02-13 |
| 05050474534469 | UNFOLDER EMERALD AR | JOHNSON & JOHNSON SURGICAL VISION, INC. | 2019-02-13 |
| 05050474530034 | UNFOLDER SILVER | JOHNSON & JOHNSON SURGICAL VISION, INC. | 2019-02-13 |
| 05050474530027 | UNFOLDER EMERALD | JOHNSON & JOHNSON SURGICAL VISION, INC. | 2019-02-13 |
| M687PR104013 | Lens Exchange Sytem | VISIONCARE OPHTHALMIC TECHNOLOGIES LTD. | 2017-06-01 |
| M687PR103013 | Lens Exchange Sytem | VISIONCARE OPHTHALMIC TECHNOLOGIES LTD. | 2017-06-01 |