System, Non-coherent Light, Photodynamic Therapy

Device Code: 5947

Product Code(s): MYH

Device Classification Information

Device Type ID5947
Device NameSystem, Non-coherent Light, Photodynamic Therapy
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 TypePMA
FDA Device ClassificationClass 3 Medical Device
Product CodeMYH
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5947
DeviceSystem, Non-coherent Light, Photodynamic Therapy
Product CodeMYH
FDA Device ClassificationClass 3 Medical Device
TPLC Last Update: 2019-04-02 21:15:04

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