Prism, Fresnel, Ophthalmic

Device Code: 4178

Product Code(s): HKT

Device Classification Information

Device Type ID4178
Device NamePrism, Fresnel, Ophthalmic
Regulation DescriptionOphthalmic Fresnel Prism.
Regulation Medical SpecialtyOphthalmic
Review PanelOphthalmic
Premarket Review Office Of Device Evaluation (ODE)
Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED)
Diagnostic And Surgical Devices Branch (DSDB)
Submission Type510(K) Exempt
CFR Regulation Number886.1655 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeHKT
GMP ExemptYes
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4178
DevicePrism, Fresnel, Ophthalmic
Product CodeHKT
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionOphthalmic Fresnel Prism.
CFR Regulation Number886.1655 [🔎]
TPLC Last Update: 2019-04-02 20:44:15

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