Magnifier, Hand-held, Low-vision

Device Code: 4145

Product Code(s): HJF

Device Classification Information

Device Type ID4145
Device NameMagnifier, Hand-held, Low-vision
Regulation DescriptionLow-vision Magnifier.
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 Number886.5540 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeHJF
GMP ExemptYes
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4145
DeviceMagnifier, Hand-held, Low-vision
Product CodeHJF
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionLow-vision Magnifier.
CFR Regulation Number886.5540 [🔎]
Device Problems
Device Damaged Prior To Use
1
Total Device Problems 1
TPLC Last Update: 2019-04-02 20:43:45

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