Illuminator, Color Vision Plate

Device Code: 4144

Product Code(s): HJD

Device Classification Information

Device Type ID4144
Device NameIlluminator, Color Vision Plate
Regulation DescriptionColor Vision Plate Illuminator.
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 Number886.1160 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeHJD
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4144
DeviceIlluminator, Color Vision Plate
Product CodeHJD
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionColor Vision Plate Illuminator.
CFR Regulation Number886.1160 [🔎]
TPLC Last Update: 2019-04-02 20:43:43

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