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.
Recent Cleared Devices (20 of 39)
Showing 20 most recent of 39 cleared devices.
| 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 |
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
