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510(k) Data Aggregation
K Number
K233760Device Name
Mjolnir Pro. (Multielectrode plasma)
Manufacturer
Shenzhen Leaflife Technology Co., Ltd
Date Cleared
2024-02-20
(88 days)
Product Code
QVJ
Regulation Number
878.4400Why did this record match?
Product Code :
QVJ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Mjolnir Pro. With single-electrode plasma tip is used in the removal and destruction of skin lesions and coagulation of tissue.
Mjolnir Pro. With Multi-electrode plasma tip is intended for use in dermatologic and general surgical procedures for coagulation and hemostasis.
Device Description
Mjolnir Pro. With single-electrode plasma tip is used in the removal and destruction of skin lesions and coagulation of tissue. With Multi-electrode plasma tip is intended for use in dermatologic and general surgical procedures for coagulation and hemostasis. Under the controllable way, the device utilizes a treatment method called plasma sublimation, which causes controlled skin damage through the generation of an electrical arc. The arc between the electrode tip and the skin is created by a radio frequency generator housed in an electrosurgical unit (handpiece) that ionizes the gas particles in the air. A straight active electrode made of 316 stainless steel is available with the system.
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K Number
K220493Device Name
Plaxpot Multi Plasma
Manufacturer
GCS Co. Limited
Date Cleared
2023-10-27
(612 days)
Product Code
QVJ
Regulation Number
878.4400Why did this record match?
Product Code :
QVJ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
PLAXPOT™ MULTI PLASMA is intended for the removal and destruction of skin lesions and coagulation of tissue.
Device Description
PLAXPOT™ MULTI PLASMA is a device that consists of a handpiece which is the main body and a charger (charging cradle, and power adapter). The high frequency current is exposed to the air and the air is ionized. The electrode tip can perform treatment without direct contact with the tissue. After the power is applied through the internal battery, the mode is set and the Shot button is pressed, a high voltage alternating current pulse is released according to the set value, and the air is ionized to form a plasma arc. This device uses plasma energy. This causes excess skink and sublimate (direct passage from the solid to the gaseous state of matter) without affecting the deeper skin layers. The difference in potential distance between device's handpiece and the skin represents the area where the voltaic arc will take place. In this gap, the gases in the air are ionized, thus Plasma is generated. The tissues touched by plasma "sublime" without heat transfer to other unwanted tissues.
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K Number
K213247Device Name
JETT PLASMA Medical II
Manufacturer
Compex, Spol. s.r.o
Date Cleared
2023-03-14
(530 days)
Product Code
QVJ
Regulation Number
878.4400Why did this record match?
Product Code :
QVJ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
JETT PLASMA Medical II is used in the removal and destruction of skin lesions and coagulation of tissue.
Device Description
Not Found
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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?
Product Code :
QVJ
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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