Static Electricity-emitting Device, Cosmetic Use

Device Code: 5953

Product Code(s): NZF

Definition: Intended For Relaxation And Cosmetic Use.

Device Classification Information

Device Type ID5953
Device NameStatic Electricity-emitting Device, Cosmetic Use
Physical StateHand Held Bulb And The Bulb Creates Static Electricity That Is Applied To The Skin.
Technical MethodApplication Of Static Electricity To Skin.
Target AreaSkin
Review PanelGeneral & Plastic Surgery
Premarket Review Office Of Device Evaluation (ODE)
Division Of Neurological And Physical Medicine Devices (DNPMD)
Physical Medicine And Rehabilitation Devices Branch (PMDB)
Submission TypeEnforcement Discretion
FDA Device ClassificationClass Not Classified Medical Device
Product CodeNZF
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5953
DeviceStatic Electricity-emitting Device, Cosmetic Use
Product CodeNZF
TPLC Last Update: 2019-04-02 21:15:10

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