Lens, Contact, For Color Vision Deficiency

Device Code: 4373

Product Code(s): NCZ

Device Classification Information

Device Type ID4373
Device NameLens, Contact, For Color Vision Deficiency
Regulation DescriptionSoft (hydrophilic) Contact Lens.
Regulation Medical SpecialtyOphthalmic
Review PanelOphthalmic
Premarket Review Office Of Device Evaluation (ODE)
Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED)
Contact Lenses And Retinal Devices Branch (CLRD)
Submission Type510(k)
CFR Regulation Number886.5925 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeNCZ
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4373
DeviceLens, Contact, For Color Vision Deficiency
Product CodeNCZ
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionSoft (hydrophilic) Contact Lens.
CFR Regulation Number886.5925 [🔎]
TPLC Last Update: 2019-04-02 20:47:55

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