Device, Measuring, Lens Radius, Ophthalmic

Device Code: 4187

Product Code(s): HLF

Device Classification Information

Device Type ID4187
Device NameDevice, Measuring, Lens Radius, Ophthalmic
Regulation DescriptionOphthalmic Contact Lens Radius Measuring Device.
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 Number886.1430 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeHLF
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4187
DeviceDevice, Measuring, Lens Radius, Ophthalmic
Product CodeHLF
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionOphthalmic Contact Lens Radius Measuring Device.
CFR Regulation Number886.1430 [🔎]
TPLC Last Update: 2019-04-02 20:44:24

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