Implant, Eye Sphere

Device Code: 4289

Product Code(s): HPZ

Device Classification Information

Device Type ID4289
Device NameImplant, Eye Sphere
Regulation DescriptionEye Sphere Implant.
Regulation Medical SpecialtyOphthalmic
Review PanelOphthalmic
Premarket Review Office Of Device Evaluation (ODE)
Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED)
Intraocular And Corneal Implants Devices Branch (ICIB)
Submission Type510(k)
CFR Regulation Number886.3320 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeHPZ
GMP ExemptNo
Summary MREligible
Implanted DeviceYes
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4289
DeviceImplant, Eye Sphere
Product CodeHPZ
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionEye Sphere Implant.
CFR Regulation Number886.3320 [🔎]
TPLC Last Update: 2019-04-02 20:46:12

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