Flasher, Afterimage, Ophthalmic

Device Code: 4379

Product Code(s): NJG

Device Classification Information

Device Type ID4379
Device NameFlasher, Afterimage, Ophthalmic
Regulation DescriptionAfterimage Flasher.
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 Number886.1300 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeNJG
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 ID4379
DeviceFlasher, Afterimage, Ophthalmic
Product CodeNJG
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionAfterimage Flasher.
CFR Regulation Number886.1300 [🔎]
TPLC Last Update: 2019-04-02 20:48:02

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