FDA Product Code
FDA Product Code KYB — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Ophthalmic
- 21 CFR Citation
- 886.4300
510(k) Clearances — 39 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K152357 | MicroSTAAR Injector System Cartridges | STAAR Surgical Company | 2015-10-30 | Special | PDF ↗ |
| K081382 | DUCKWORTH & KENT, LTD., IMPLANTATION SYSTEM, MODEL DK7786 | Duckworth & Kent, Ltd. | 2008-10-23 | Traditional | PDF ↗ |
| K072985 | DUCKWORTH & KENT LTD INJECTOR, MODEL: DK7797-2 | Duckworth & Kent, Ltd. | 2008-06-20 | Traditional | PDF ↗ |
| K070669 | IOL INJECTOR SET | Medicel AG | 2007-11-01 | Traditional | PDF ↗ |
| K063155 | MONARCH III IOL DELIVERY SYSTEM | Alcon Manufacturing, Ltd. | 2007-03-27 | Traditional | PDF ↗ |
| K063694 | AKREOS SINGLE USE INSERTION DEVICE, MODEL AI-28 | Bausch & Lomb, Inc. | 2007-03-07 | Special | PDF ↗ |
| K032412 | RE-USEABLE MICROSTAAR INJECTOR, MSI-S | Staar Surgical Co. | 2004-06-10 | Traditional | PDF ↗ |
| K022723 | MASTEL 1 FOLDER IMPLANTATION SYSTEM | Mastel Precision, Inc. | 2002-12-26 | Traditional | PDF ↗ |
| K001157 | MONARCH II IOL DELIVERY SYSTEM | Alcon Research, Ltd. | 2000-06-27 | Traditional | PDF ↗ |
| K983129 | DISPOSABLE MICROSTAAR INJECTOR (MODEL MSI-P1) | Staar Surgical Co. | 1998-12-04 | Traditional | PDF ↗ |
| K981571 | MONARCH IOL DELIVERY SYSTEM | Alcon Laboratories | 1998-07-09 | Traditional | PDF ↗ |
| K970033 | MONARCH IOL DELIVERY SYSTEM | Alcon Laboratories | 1997-04-23 | Traditional | PDF ↗ |
| K965185 | ACRYPAK FOLDER | Alcon Laboratories | 1997-03-31 | Traditional | PDF ↗ |
| K961242 | AMO PHACOFLEX II INTERSECTION SYSTEM | Allergan, Inc. | 1996-06-17 | Traditional | PDF ↗ |
| K954600 | MICROSTAAR INJECTOR MODELS MSI-TD & MSI-PD (MODIFICATION) | Staar Surgical Co. | 1995-12-21 | Traditional | PDF ↗ |
| K951292 | PASSPORT FOLDABLE LENS PLACEMENT SYSTEM | Chiron Vision Corp. | 1995-06-02 | Traditional | PDF ↗ |
| K930628 | KLAAS IOL LENSFOLDER | Bova Intl. | 1995-02-07 | Traditional | PDF ↗ |
| K940593 | DISPOSABLE MICROSTAAR INJECTOR | Staar Sugical | 1994-09-19 | Traditional | PDF ↗ |
| K941603 | AMO PHACOFLEX INSERTER DISPOSABLE CARTRIDGE, AND HANDPIECE | Allergan Medical Optics | 1994-07-06 | Traditional | PDF ↗ |
| K930320 | AMO PHACOFLEX INSERTER, FOLDABLE IOL INSERT INSTR | Allergan Medical Optics | 1994-04-07 | Traditional | PDF ↗ |
| K903575 | CHIROFLEX FORCEPS | Chiron Ophthalmics | 1990-12-21 | Traditional | PDF ↗ |
| K903574 | CHIROFLEX LENS MICROSERT | Chiron Ophthalmics | 1990-09-17 | Traditional | PDF ↗ |
| K883489 | KRATZ NOVA SERT(TM) | Coopervision-Cilco | 1988-10-25 | Traditional | PDF ↗ |
| K871440 | KRATZ NOVA-SERT | CooperVision, Inc. | 1987-05-07 | Traditional | PDF ↗ |
| K870265 | KRATZ NOVA-SERT. SOFT INTRAOCULAR LENS INJECTOR | CooperVision, Inc. | 1987-02-20 | Traditional | PDF ↗ |
| K861990 | SOFT LENS FOLDER | Staar Surgical Co. | 1986-06-17 | Traditional | PDF ↗ |
| K861085 | ELASTIC LENS INJECTOR TM | Staar Surgical Co. | 1986-05-28 | Traditional | PDF ↗ |
| K860148 | MAZZOCCO/FRENCHIK FOLDER | Staar Surgical Co. | 1986-03-21 | Traditional | PDF ↗ |
| K854994 | BARTELL SMALL INCISION LENS GLIDE | Microtech, Inc. | 1986-02-04 | Traditional | PDF ↗ |
| K854197 | IOSERT LENS IMPLANT INSTRUMENT | Chiron Vision Corp. | 1986-01-22 | Traditional | PDF ↗ |
| K841730 | BAILEY LENS SHOOTER | Intermedics Intraocular, Inc. | 1984-11-19 | Traditional | PDF ↗ |
| K840694 | LENS INSERTION GLIDE | Innovative Surgical Products, Inc. | 1984-05-09 | Traditional | PDF ↗ |
| K840104 | PETRUS IOL GUIDE | Precision-Cosmet Co., Inc. | 1984-04-24 | Traditional | PDF ↗ |
| K832939 | I-GLIDE IOL IMPLANTATION AID | I For M, Inc. | 1983-10-04 | Traditional | PDF ↗ |
| K823222 | INTRAOCULAR LENS GUIDE | American Medical Optics | 1982-12-28 | Traditional | PDF ↗ |
| K821381 | IOL FORCEPS | Cilco, Inc. | 1982-06-14 | Traditional | PDF ↗ |
| K811718 | SURFACE REPLACEMENT HIP PROSTHESIS | Biomet, Inc. | 1981-09-18 | Traditional | PDF ↗ |
| K792066 | M.P.I. LENS GLIDE | J. Leon Bilby | 1980-01-29 | Traditional | PDF ↗ |
| K791351 | CEMENT SPACERS | Depuy, Inc. | 1979-08-03 | Traditional | PDF ↗ |
Product code KYB · Class I · Ophthalmic. Data: openFDA.