Lamp, Uvc, (for Treating Skin And Wounds)

Device Code: 5754

Product Code(s): MXG

Device Classification Information

Device Type ID5754
Device NameLamp, Uvc, (for Treating Skin And Wounds)
Regulation DescriptionUltraviolet Lamp For Dermatologic Disorders.
Regulation Medical SpecialtyGeneral & Plastic Surgery
Review PanelGeneral & Plastic Surgery
Premarket Review Office Of Device Evaluation (ODE)
Division Of Surgical Devices (DSD)
General Surgery Devices Branch One - Light Based/Laser (GSDB1)
Submission Type510(k)
CFR Regulation Number878.4630 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeMXG
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5754
DeviceLamp, Uvc, (for Treating Skin And Wounds)
Product CodeMXG
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionUltraviolet Lamp For Dermatologic Disorders.
CFR Regulation Number878.4630 [🔎]
TPLC Last Update: 2019-04-02 21:11:58

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