Anesthesiology
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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
- 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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Button, Iris, Eye, Artificial
- Page Type
- Product Code
- Regulation Medical Specialty
- Ophthalmic
- Review Panel
- Ophthalmic
- Submission Type
- 510(K) Exempt
- Device Classification
- Class 1
- Regulation Number
- 886.3200
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Eligible
- Implanted Device
- No
- Life-Sustain/Support Device
- No
- Third Party Review
- Not Third Party Eligible
- MAUDE Alerts
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CFR § 886.3200 Artificial eye
§ 886.3200 Artificial eye.
(a) Identification. An artificial eye is a device resembling the anterior portion of the eye, usually made of glass or plastic, intended to be inserted in a patient's eye socket anterior to an orbital implant, or the eviscerated eyeball, for cosmetic purposes. The device is not intended to be implanted.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9, if the device is made from the same materials, has the same chemical composition, and uses the same manufacturing processes as currently legally marketed devices.
[61 FR 1124, Jan. 16, 1996, as amended at 66 FR 38813, July 25, 2001]