510(k) K220032
- Device
- IStent Infinite Trabecular Micro-Bypass System, Model IS3
- Applicant
- Glaukos Corporation
- 510(k) number
- K220032
- Product code
- KYF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-08-02
- Date received
- 2022-01-05
- Regulation
- 886.3920
- Classification name
- Implant, Eye Valve
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- David S. Fernquist
- Address
- 229 Avenida Fabricante San Clemente CA US 92672 92672
FDA Registration Numbers#
- 3015217553
- 3012833022
- 3003701944
- 1319660
- 3009756327
- 3001227772
- 3023475296
- 1000125279
- 3012236936
- 3015456951
- 9614546
- 2523835
- 2022502
- 2022435
- 2011068
- 2029275
- 1649518
Source Documents#
Other 510(k) Records For Product Code KYF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K230975 | Ahmed® Glaucoma Valve Model FP7 | New World Medical, Inc. | 2023-05-12 |
| K231051 | Ahmed® Glaucoma Valve Model FP8 | New World Medical, Inc. | 2023-05-12 |
| K182518 | AHMED ClearPath Glaucoma Drainage Device | New World Medical, Inc. | 2019-01-18 |
| K171451 | Ahmed Glaucoma Valve Model FP8 | New World Medical, Inc. | 2017-08-08 |
| K161457 | XEN Glaucoma Treatment System | Allergan, Inc. | 2016-11-21 |
| K162060 | Ahmed Glaucoma Valve | New World Medical, Inc. | 2016-10-24 |
| K152996 | Molteno3 Glaucoma Implant | Innovative Ophthalmic Products, Inc. (Iop) | 2015-12-17 |
| K062252 | MOLTENO3 | Iop, Inc. | 2006-09-27 |
| K060644 | AHMED GLAUCOMA VALVE, MODEL M4 | New World Medical, Inc. | 2006-09-18 |
| K030350 | EXPRESS MINI GLAUCOMA SHUNT | Optonol, Ltd. | 2003-03-13 |
| K012852 | EX-PRESS MINATURE GLAUCOMA IMPLANT, MODELS R-20, R-30, R-50, STS VERSIONS | Optonol, Ltd. | 2002-03-26 |
| K991072 | AHMED GLAUCOMA VALVE IMPLANT | New World Medical, Inc. | 1999-07-13 |
| K980657 | AHMED GLAUCOMA VALVE, MODEL S3 | New World Medical, Inc. | 1998-04-20 |
| K955455 | BAERVELT PARS PLANA GLAUCOMA IMPLANT | Pharmacia Iovision, Inc. | 1997-02-18 |
| K925636 | AHMED GLAUCOMA VALVE IMPLANT | New World Medical, Inc. | 1993-11-12 |
Legacy Summary#
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FDA Review#
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