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- Diagnostic DevicesCFR Sub-Part
- General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- MiscellaneousMiscellaneous
- 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
- 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
- Surgical DevicesCFR Sub-Part
- Therapeutic DevicesCFR Sub-Part
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Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)
- Page Type
- Product Code
- Definition
- The system consists of an intraocular lens and an external energy source. The lens is intended to be implanted to replace the natural lens of an eye. The external energy source is used to postoperatively alter the properties of the lens material to reduce the likelihood of clinically significant postoperative refractive error.
- Physical State
- An intraocular lens made of a polymeric material with an appropriate shape to be implanted to replace the natural lens of an eye after cataract surgery. The energy source is a device that produces an appropriate external energy source to alter the shape or optical properties of the lens.
- Technical Method
- The intraocular lens is implanted within the eye and the external energy source is used to alter the material property within the lens to compensate for postoperative refractive error.
- Target Area
- Eye
- Regulation Medical Specialty
- Ophthalmic
- Review Panel
- Ophthalmic
- Submission Type
- PMA
- Device Classification
- Class 3
- Regulation Number
- 886.3600
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Ineligible
- Implanted Device
- Yes
- Life-Sustain/Support Device
- No
- Third Party Review
- Not Third Party Eligible
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CFR § 886.3600 Intraocular lens
§ 886.3600 Intraocular lens.
(a) Identification. An intraocular lens is a device made of materials such as glass or plastic intended to be implanted to replace the natural lens of an eye.
(b) Classification. Class III.
(c) Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before this device may be commercially distributed. See § 886.3.