Instrument, Visual Field, Laser

Device Code: 4277

Product Code(s): HPJ

Device Classification Information

Device Type ID4277
Device NameInstrument, Visual Field, Laser
Regulation DescriptionVisual Field Laser Instrument.
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)
CFR Regulation Number886.1360 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeHPJ
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

Total Product Life Cycle

Device Type ID4277
DeviceInstrument, Visual Field, Laser
Product CodeHPJ
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionVisual Field Laser Instrument.
CFR Regulation Number886.1360 [🔎]
TPLC Last Update: 2019-04-02 20:46:00

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