Lens, Prescription, Color Deficiency

Device Code: 4368

Product Code(s): NAI

Device Classification Information

Device Type ID4368
Device NameLens, Prescription, Color Deficiency
Regulation DescriptionPrescription Spectacle Lens.
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 Number886.5844 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeNAI
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4368
DeviceLens, Prescription, Color Deficiency
Product CodeNAI
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionPrescription Spectacle Lens.
CFR Regulation Number886.5844 [🔎]
TPLC Last Update: 2019-04-02 20:47:51

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