Electrosurgical Coagulation For Aesthetic

Device Code: 5818

Product Code(s): ONQ

Definition: For The Treatment Of Spider Vein Or Telangiectasia By Thermocoagulation.

Device Classification Information

Device Type ID5818
Device NameElectrosurgical Coagulation For Aesthetic
Physical StateElectrosurgical Generator And Needle Electrodes
Technical MethodHigh Frequency Radio Wave Energy
Target AreaSmall Surface Blood Vessels
Regulation DescriptionElectrosurgical Cutting And Coagulation Device And Accessories.
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 Two - Surgical (GSDB2)
Submission Type510(k)
CFR Regulation Number878.4400 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeONQ
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Program

Recognized Standards

Total Product Life Cycle

Device Type ID5818
DeviceElectrosurgical Coagulation For Aesthetic
Product CodeONQ
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionElectrosurgical Cutting And Coagulation Device And Accessories.
CFR Regulation Number878.4400 [🔎]
TPLC Last Update: 2019-04-02 21:12:54

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