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- 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
- P240038FINEVISION HP Trifocal IOLsAPPRPMA Approval
- P190018Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon Toric Aspheric Hydrophobic Acrylic Intraocular LensAPPRPMA Approval
- P100016EC-3 INTRAOCULAR LENS (IOL) AND EC-3 PRECISION ASPHERIC LENS (PAL) IOLAPPRPMA Approval
- P090022LENSTEC SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENSAPPRPMA Approval
- P080021XACT FOLDABLE HYDROPHOBIC ACRYLIC ULTRAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (IOL)APPRPMA Approval
- P080004HOYA ISPHERIC MODEL YA-60BB INTRAOCULAR LENSAPPRPMA Approval
- P060022AKREOS POSTERIOR CHAMBER INTRAOCULAR LENS,MODEL ADAPTAPPRPMA Approval
- P060011C-FLEX MODEL 570C INTRAOCULAR LENS (IOL)APPRPMA Approval
- P010027ANTERIOR CHAMBER INTRAOCULAR LENS (CATARACT)APWDPMA Approval
- P990080CEEON EDGE FOLDABLE ULTRAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS, MODEL 911AAPPRPMA Approval
Show All 66 Submissions
- HQMKeratoprosthesis, Permanent Implant2Product Code
- HQNConformer, Ophthalmic2Product Code
- HQTShell, Scleral2Product Code
- HQWClip, Tantalum, Ophthalmic2Product Code
- HQXImplant, Orbital, Extra-Ocular2Product Code
- KYFImplant, Eye Valve2Product Code
- 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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Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon Toric Aspheric Hydrophobic Acrylic Intraocular Lens
- Page Type
- PMA Approval
- Full PDF / Letter* The FDA doesn't provide PDFs for all submissions.
- Applicant
- Alcon Research, Ltd.
- Trade Name
- Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon Toric Aspheric Hydrophobic Acrylic Intraocular Lens
- Generic Name
- intraocular lens
- Decision Date
- 1/7/2020
- Days to Decision
- 180 days
- Decision Code
- APPR
- FDA Decision
- Approval