Sunglasses (non-prescription Including Photosensitive)

Device Code: 4310

Product Code(s): HQY

Device Classification Information

Device Type ID4310
Device NameSunglasses (non-prescription Including Photosensitive)
Regulation DescriptionSunglasses (nonprescription).
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 Number886.5850 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeHQY
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4310
DeviceSunglasses (non-prescription Including Photosensitive)
Product CodeHQY
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionSunglasses (nonprescription).
CFR Regulation Number886.5850 [🔎]
TPLC Last Update: 2019-04-02 20:46:45

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