Aid, Vision Image Intensification

Device Code: 4264

Product Code(s): HOT

Device Classification Information

Device Type ID4264
Device NameAid, Vision Image Intensification
Regulation DescriptionImage Intensification Vision Aid.
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 Number886.5910 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeHOT
GMP ExemptYes
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4264
DeviceAid, Vision Image Intensification
Product CodeHOT
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionImage Intensification Vision Aid.
CFR Regulation Number886.5910 [🔎]
TPLC Last Update: 2019-04-02 20:45:45

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