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- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- HPZImplant, Eye Sphere2Product Code
- HQHEye, Artificial, Non-Custom1Product Code
- HQJImplant, Absorbable, (Scleral Buckling Methods)2Product Code
- HQLIntraocular Lens3Product Code
- HQMKeratoprosthesis, Permanent Implant2Product Code
- HQNConformer, Ophthalmic2Product Code
- HQTShell, Scleral2Product Code
- HQWClip, Tantalum, Ophthalmic2Product Code
- HQXImplant, Orbital, Extra-Ocular2Product Code
- KYFImplant, Eye Valve2Product Code
- K231051Ahmed® Glaucoma Valve Model FP82Cleared 510(K)
- K230975Ahmed® Glaucoma Valve Model FP72Cleared 510(K)
- K220032iStent infinite Trabecular Micro-Bypass System, Model iS32Cleared 510(K)
- K182518AHMED ClearPath Glaucoma Drainage Device2Cleared 510(K)
- K171451Ahmed Glaucoma Valve Model FP82Cleared 510(K)
- K161457XEN Glaucoma Treatment System2Cleared 510(K)
- K162060Ahmed Glaucoma Valve2Cleared 510(K)
- K152996Molteno3 Glaucoma Implant2Cleared 510(K)
- K062252MOLTENO32Cleared 510(K)
- K060644AHMED GLAUCOMA VALVE, MODEL M42Cleared 510(K)
- K030350EXPRESS MINI GLAUCOMA SHUNT2Cleared 510(K)
- K012852EX-PRESS MINATURE GLAUCOMA IMPLANT, MODELS R-20, R-30, R-50, STS VERSIONS2Cleared 510(K)
- K991072AHMED GLAUCOMA VALVE IMPLANT2Cleared 510(K)
- K980657AHMED GLAUCOMA VALVE, MODEL S32Cleared 510(K)
- K955455BAERVELT PARS PLANA GLAUCOMA IMPLANT2Cleared 510(K)
- K925636AHMED GLAUCOMA VALVE IMPLANT2Cleared 510(K)
- K905703KRUPIN EYE VALVE WITH DISK2Cleared 510(K)
- K902296TRABECULO-SUPRACHOROIDAL SHUNT2Cleared 510(K)
- K905129BAERVELDT GLAUCOMA IMPLANT2Cleared 510(K)
- K903462OPTIMED GLAUCOMA PRESSURE REGULATOR2Cleared 510(K)
- K902489MODIFIED MOLTENO(TM) IMPLANTS2Cleared 510(K)
- K890598MOLTENO IMPLANT2Cleared 510(K)
- K885125KRUPIN EYE VALVE W/SCLERAL BUCKLE2Cleared 510(K)
- K875099MOLTENO VALVE SETON2Cleared 510(K)
- K840204WHITE OCULAR PRESSURE RELIEF DEVICE2Cleared 510(K)
- MFKLens, Multifocal Intraocular3Product Code
- MJPLens, Intraocular, Toric Optics3Product Code
- MLPKeratoprosthesis, Temporary Implant, Surgical Use2Product Code
- MQUOcular Peg2Product Code
- MTZWrap, Implant, Orbital2Product Code
- NAALens, Intraocular, Accommodative3Product Code
- NCKButton, Iris, Eye, Artificial1Product Code
- NFMExpander, Tissue, Orbital2Product Code
- NIZLens, Iris Reconstruction3Product Code
- NQBConformer, Ophthalmic, Biological Tissue2Product Code
- NXMProsthesis, Eyelid Spacer/Graft, Biologic2Product Code
- POEExtended Depth Of Focus Intraocular Lens3Product Code
- PUFOcular Peg, Exempt2Product Code
- PZKLight Adjustable Lens (Lal) And Light Delivery Device (Ldd)3Product Code
- QCBPhakic Toric Intraocular Lens3Product Code
- QWUProsthesis, Eyelid Spacer/Graft, Polymer2Product Code
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
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EX-PRESS MINATURE GLAUCOMA IMPLANT, MODELS R-20, R-30, R-50, STS VERSIONS
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K012852
- 510(k) Type
- Traditional
- Applicant
- Optonol, Ltd.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 3/26/2002
- Days to Decision
- 214 days
- Submission Type
- Summary