Aid, Vision, Optical, Ac-powered

Device Code: 4276

Product Code(s): HPI

Device Classification Information

Device Type ID4276
Device NameAid, Vision, Optical, Ac-powered
Regulation DescriptionOptical 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 Number886.5915 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeHPI
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4276
DeviceAid, Vision, Optical, Ac-powered
Product CodeHPI
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionOptical Vision Aid.
CFR Regulation Number886.5915 [🔎]
TPLC Last Update: 2019-04-02 20:45:58

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