Screen, Tangent, Target

Device Code: 4254

Product Code(s): HOJ

Device Classification Information

Device Type ID4254
Device NameScreen, Tangent, Target
Regulation DescriptionTangent Screen (campimeter).
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 Number886.1810 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeHOJ
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4254
DeviceScreen, Tangent, Target
Product CodeHOJ
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionTangent Screen (campimeter).
CFR Regulation Number886.1810 [🔎]
TPLC Last Update: 2019-04-02 20:45:35

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