Projector, Ophthalmic

Device Code: 4263

Product Code(s): HOS

Device Classification Information

Device Type ID4263
Device NameProjector, Ophthalmic
Regulation DescriptionOphthalmic Projector.
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 Number886.1680 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeHOS
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4263
DeviceProjector, Ophthalmic
Product CodeHOS
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionOphthalmic Projector.
CFR Regulation Number886.1680 [🔎]
TPLC Last Update: 2019-04-02 20:45:44

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