Frame, Trial, Ophthalmic

Device Code: 4269

Product Code(s): HPA

Device Classification Information

Device Type ID4269
Device NameFrame, Trial, Ophthalmic
Regulation DescriptionOphthalmic Trial Lens Frame.
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 Number886.1415 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeHPA
GMP ExemptYes
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4269
DeviceFrame, Trial, Ophthalmic
Product CodeHPA
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionOphthalmic Trial Lens Frame.
CFR Regulation Number886.1415 [🔎]
TPLC Last Update: 2019-04-02 20:45:50

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