KYF — Implant, Eye Valve Class II
FDA product code KYF covers "Implant, Eye Valve", a Class II medical device regulated under 21 CFR 886.3920. Submissions are reviewed by the Ophthalmic panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KYF
- Device Class
- Class II
- Regulation Number
- 886.3920
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K230975 | new world medical | Ahmed® Glaucoma Valve Model FP7 | May 12, 2023 |
| K231051 | new world medical | Ahmed® Glaucoma Valve Model FP8 | May 12, 2023 |
| K220032 | glaukos corporation | iStent infinite Trabecular Micro-Bypass System, Model iS3 | August 2, 2022 |
| K182518 | new world medical | AHMED ClearPath Glaucoma Drainage Device | January 18, 2019 |
| K171451 | new world medical | Ahmed Glaucoma Valve Model FP8 | August 8, 2017 |
| K161457 | allergan | XEN Glaucoma Treatment System | November 21, 2016 |
| K162060 | new world medical | Ahmed Glaucoma Valve | October 24, 2016 |
| K152996 | innovative ophthalmic products, inc. (iop) | Molteno3 Glaucoma Implant | December 17, 2015 |
| K062252 | iop | MOLTENO3 | September 27, 2006 |
| K060644 | new world medical | AHMED GLAUCOMA VALVE, MODEL M4 | September 18, 2006 |
| K030350 | optonol | EXPRESS MINI GLAUCOMA SHUNT | March 13, 2003 |
| K012852 | optonol | EX-PRESS MINATURE GLAUCOMA IMPLANT, MODELS R-20, R-30, R-50, STS VERSIONS | March 26, 2002 |
| K991072 | new world medical | AHMED GLAUCOMA VALVE IMPLANT | July 13, 1999 |
| K980657 | new world medical | AHMED GLAUCOMA VALVE, MODEL S3 | April 20, 1998 |
| K955455 | pharmacia iovision | BAERVELT PARS PLANA GLAUCOMA IMPLANT | February 18, 1997 |
| K925636 | new world medical | AHMED GLAUCOMA VALVE IMPLANT | November 12, 1993 |
| K905703 | hood laboratories | KRUPIN EYE VALVE WITH DISK | March 15, 1991 |
| K902296 | visionex | TRABECULO-SUPRACHOROIDAL SHUNT | March 14, 1991 |
| K905129 | wright medical | BAERVELDT GLAUCOMA IMPLANT | February 11, 1991 |
| K903462 | optimed | OPTIMED GLAUCOMA PRESSURE REGULATOR | October 16, 1990 |