Spectacle, Magnifying

Device Code: 4253

Product Code(s): HOI

Device Classification Information

Device Type ID4253
Device NameSpectacle, Magnifying
Regulation DescriptionMagnifying Spectacles.
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 Number886.5840 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeHOI
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4253
DeviceSpectacle, Magnifying
Product CodeHOI
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionMagnifying Spectacles.
CFR Regulation Number886.5840 [🔎]
TPLC Last Update: 2019-04-02 20:45:34

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