FDA Product Code
FDA Product Code KYF — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Ophthalmic
- 21 CFR Citation
- 886.3920
510(k) Clearances — 25 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K231051 | Ahmed® Glaucoma Valve Model FP8 | New World Medical, Inc. | 2023-05-12 | Special | PDF ↗ |
| K230975 | Ahmed® Glaucoma Valve Model FP7 | New World Medical, Inc. | 2023-05-12 | Special | PDF ↗ |
| K220032 | iStent infinite Trabecular Micro-Bypass System, Model iS3 | Glaukos Corporation | 2022-08-02 | Traditional | PDF ↗ |
| K182518 | AHMED ClearPath Glaucoma Drainage Device | New World Medical, Inc. | 2019-01-18 | Traditional | PDF ↗ |
| K171451 | Ahmed Glaucoma Valve Model FP8 | New World Medical, Inc. | 2017-08-08 | Traditional | PDF ↗ |
| K161457 | XEN Glaucoma Treatment System | Allergan, Inc. | 2016-11-21 | Traditional | PDF ↗ |
| K162060 | Ahmed Glaucoma Valve | New World Medical, Inc. | 2016-10-24 | Traditional | PDF ↗ |
| K152996 | Molteno3 Glaucoma Implant | Innovative Ophthalmic Products, Inc. (Iop) | 2015-12-17 | Traditional | PDF ↗ |
| K062252 | MOLTENO3 | Iop, Inc. | 2006-09-27 | Traditional | PDF ↗ |
| K060644 | AHMED GLAUCOMA VALVE, MODEL M4 | New World Medical, Inc. | 2006-09-18 | Traditional | PDF ↗ |
| K030350 | EXPRESS MINI GLAUCOMA SHUNT | Optonol, Ltd. | 2003-03-13 | Abbreviated | PDF ↗ |
| K012852 | EX-PRESS MINATURE GLAUCOMA IMPLANT, MODELS R-20, R-30, R-50, STS VERSIONS | Optonol, Ltd. | 2002-03-26 | Traditional | PDF ↗ |
| K991072 | AHMED GLAUCOMA VALVE IMPLANT | New World Medical, Inc. | 1999-07-13 | Traditional | PDF ↗ |
| K980657 | AHMED GLAUCOMA VALVE, MODEL S3 | New World Medical, Inc. | 1998-04-20 | Traditional | PDF ↗ |
| K955455 | BAERVELT PARS PLANA GLAUCOMA IMPLANT | Pharmacia Iovision, Inc. | 1997-02-18 | Traditional | PDF ↗ |
| K925636 | AHMED GLAUCOMA VALVE IMPLANT | New World Medical, Inc. | 1993-11-12 | Traditional | PDF ↗ |
| K905703 | KRUPIN EYE VALVE WITH DISK | Hood Laboratories | 1991-03-15 | Traditional | PDF ↗ |
| K902296 | TRABECULO-SUPRACHOROIDAL SHUNT | Visionex, Inc. | 1991-03-14 | Traditional | PDF ↗ |
| K905129 | BAERVELDT GLAUCOMA IMPLANT | Wright Medical Corp. | 1991-02-11 | Traditional | PDF ↗ |
| K903462 | OPTIMED GLAUCOMA PRESSURE REGULATOR | Optimed, Inc. | 1990-10-16 | Traditional | PDF ↗ |
| K902489 | MODIFIED MOLTENO(TM) IMPLANTS | Iop, Inc. | 1990-08-14 | Traditional | PDF ↗ |
| K890598 | MOLTENO IMPLANT | Iop, Inc. | 1989-02-27 | Traditional | PDF ↗ |
| K885125 | KRUPIN EYE VALVE W/SCLERAL BUCKLE | Hood Laboratories | 1989-01-24 | Traditional | PDF ↗ |
| K875099 | MOLTENO VALVE SETON | Staar Surgical Co. | 1988-03-30 | Traditional | PDF ↗ |
| K840204 | WHITE OCULAR PRESSURE RELIEF DEVICE | Precision-Cosmet Co., Inc. | 1985-02-15 | Traditional | PDF ↗ |
Product code KYF · Class II · Ophthalmic. Data: openFDA.