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510(k) Data Aggregation
K Number
K223440Device Name
Plasma Pen (Plasma MD); Plasma Pen (Plasma +)
Manufacturer
Plasma Concepts
Date Cleared
2023-03-02
(108 days)
Product Code
QVJ, GEI, OVJ
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
Plasma Concepts
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Plasma MD or Plasma + is intended for the removal and destruction of skin lesions and coagulation of tissue.
Device Description
The Plasma Pen utilizes a treatment method called plasma sublimation, which causes controlled skin damage through the generation of an electrical arc. The arc between the disposable tip and the skin is created by a radio frequency generator housed in an electrosurqical unit (handpiece) that ionizes the gas particles in the air. A straight disposable tip is available with the system. The handheld device is cordless and is charged in a docking/charging station prior to use.
The system components include the following:
1. Plasma Pen (Plasma MD (with 2 level switch) and Plasma+ (without switch)
2. Docking station for Plasma Pen
3. Cable for Plasma Pen
4. Power bank battery
5. Cable for power bank battery
6. Charging Block
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