KYB · Lens, Guide, Intraocular
Ophthalmic · 21 CFR 886.4300 · Class 1
Overview
| Product Code | KYB |
|---|---|
| Device Name | Lens, Guide, Intraocular |
| Regulation | 21 CFR 886.4300 |
| Device Class | Class 1 |
| Review Panel | Ophthalmic |
Identification
An intraocular lens guide is a device intended to be inserted into the eye during surgery to direct the insertion of an intraocular lens and be removed after insertion is completed.
Classification Rationale
Class I (general controls). Except when used as folders or injectors for soft or foldable intraocular lenses, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 886.9.
Cleared Devices (39)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K152357 | MicroSTAAR Injector System Cartridges | STAAR Surgical Company | Oct 30, 2015 | SESE |
| K081382 | DUCKWORTH & KENT, LTD., IMPLANTATION SYSTEM, MODEL DK7786 | Duckworth & Kent, Ltd. | Oct 23, 2008 | SESE |
| K072985 | DUCKWORTH & KENT LTD INJECTOR, MODEL: DK7797-2 | Duckworth & Kent, Ltd. | Jun 20, 2008 | SESE |
| K070669 | IOL INJECTOR SET | Medicel AG | Nov 1, 2007 | SESE |
| K063155 | MONARCH III IOL DELIVERY SYSTEM | Alcon Manufacturing, Ltd. | Mar 27, 2007 | SESE |
| K063694 | AKREOS SINGLE USE INSERTION DEVICE, MODEL AI-28 | Bausch & Lomb, Inc. | Mar 7, 2007 | SESE |
| K032412 | RE-USEABLE MICROSTAAR INJECTOR, MSI-S | Staar Surgical Co. | Jun 10, 2004 | SESE |
| K022723 | MASTEL 1 FOLDER IMPLANTATION SYSTEM | Mastel Precision, Inc. | Dec 26, 2002 | SESE |
| K001157 | MONARCH II IOL DELIVERY SYSTEM | Alcon Research, Ltd. | Jun 27, 2000 | SESE |
| K983129 | DISPOSABLE MICROSTAAR INJECTOR (MODEL MSI-P1) | Staar Surgical Co. | Dec 4, 1998 | SESE |
| K981571 | MONARCH IOL DELIVERY SYSTEM | Alcon Laboratories | Jul 9, 1998 | SESE |
| K970033 | MONARCH IOL DELIVERY SYSTEM | Alcon Laboratories | Apr 23, 1997 | SESE |
| K965185 | ACRYPAK FOLDER | Alcon Laboratories | Mar 31, 1997 | SESE |
| K961242 | AMO PHACOFLEX II INTERSECTION SYSTEM | Allergan, Inc. | Jun 17, 1996 | SESE |
| K954600 | MICROSTAAR INJECTOR MODELS MSI-TD & MSI-PD (MODIFICATION) | Staar Surgical Co. | Dec 21, 1995 | SESE |
| K951292 | PASSPORT FOLDABLE LENS PLACEMENT SYSTEM | Chiron Vision Corp. | Jun 2, 1995 | SESE |
| K930628 | KLAAS IOL LENSFOLDER | Bova Intl. | Feb 7, 1995 | SESE |
| K940593 | DISPOSABLE MICROSTAAR INJECTOR | Staar Sugical | Sep 19, 1994 | SESE |
| K941603 | AMO PHACOFLEX INSERTER DISPOSABLE CARTRIDGE, AND HANDPIECE | Allergan Medical Optics | Jul 6, 1994 | SESE |
| K930320 | AMO PHACOFLEX INSERTER, FOLDABLE IOL INSERT INSTR | Allergan Medical Optics | Apr 7, 1994 | SESE |
| K903575 | CHIROFLEX FORCEPS | Chiron Ophthalmics | Dec 21, 1990 | SESE |
| K903574 | CHIROFLEX LENS MICROSERT | Chiron Ophthalmics | Sep 17, 1990 | SESE |
| K883489 | KRATZ NOVA SERT(TM) | Coopervision-Cilco | Oct 25, 1988 | SESE |
| K871440 | KRATZ NOVA-SERT | CooperVision, Inc. | May 7, 1987 | SESE |
| K870265 | KRATZ NOVA-SERT. SOFT INTRAOCULAR LENS INJECTOR | CooperVision, Inc. | Feb 20, 1987 | SESE |
| K861990 | SOFT LENS FOLDER | Staar Surgical Co. | Jun 17, 1986 | SESE |
| K861085 | ELASTIC LENS INJECTOR TM | Staar Surgical Co. | May 28, 1986 | SESE |
| K860148 | MAZZOCCO/FRENCHIK FOLDER | Staar Surgical Co. | Mar 21, 1986 | SESE |
| K854994 | BARTELL SMALL INCISION LENS GLIDE | Microtech, Inc. | Feb 4, 1986 | SESE |
| K854197 | IOSERT LENS IMPLANT INSTRUMENT | Chiron Vision Corp. | Jan 22, 1986 | SESE |
| K841730 | BAILEY LENS SHOOTER | Intermedics Intraocular, Inc. | Nov 19, 1984 | SESE |
| K840694 | LENS INSERTION GLIDE | Innovative Surgical Products, Inc. | May 9, 1984 | SESE |
| K840104 | PETRUS IOL GUIDE | Precision-Cosmet Co., Inc. | Apr 24, 1984 | SESE |
| K832939 | I-GLIDE IOL IMPLANTATION AID | I For M, Inc. | Oct 4, 1983 | SESE |
| K823222 | INTRAOCULAR LENS GUIDE | American Medical Optics | Dec 28, 1982 | SESE |
| K821381 | IOL FORCEPS | Cilco, Inc. | Jun 14, 1982 | SESE |
| K811718 | SURFACE REPLACEMENT HIP PROSTHESIS | Biomet, Inc. | Sep 18, 1981 | SESE |
| K792066 | M.P.I. LENS GLIDE | J. Leon Bilby | Jan 29, 1980 | SESE |
| K791351 | CEMENT SPACERS | Depuy, Inc. | Aug 3, 1979 | SESE |
Top Applicants
- Staar Surgical Co. — 6 clearances
- Alcon Laboratories — 3 clearances
- Duckworth & Kent, Ltd. — 2 clearances
- CooperVision, Inc. — 2 clearances
- Chiron Vision Corp. — 2 clearances
