Perimeter, Automatic, Ac-powered

Device Code: 4286

Product Code(s): HPT

Device Classification Information

Device Type ID4286
Device NamePerimeter, Automatic, Ac-powered
Regulation DescriptionPerimeter.
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 Number886.1605 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeHPT
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4286
DevicePerimeter, Automatic, Ac-powered
Product CodeHPT
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionPerimeter.
CFR Regulation Number886.1605 [🔎]
Device Problems
Adverse Event Without Identified Device Or Use Problem
1
Total Device Problems 1
TPLC Last Update: 2019-04-02 20:46:09

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