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510(k) Data Aggregation
K Number
K223222Device Name
Plasma IQ
Manufacturer
Neauvia North America, Inc
Date Cleared
2023-01-17
(92 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
Neauvia North America, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
PLASMA IQ is used in the removal and destruction of skin lesions and coagulation of tissue.
Device Description
PLASMA IQ 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 316L stainless steel is available with the system. The handheld device is cordless and is charged in a docking/charging station prior to use.
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K Number
K212329Device Name
Plasma IQ
Manufacturer
Neauvia North America, Inc
Date Cleared
2021-12-09
(135 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
Neauvia North America, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
PLASMA IQ is used in the removal and destruction of skin lesions and coagulation of tissue.
Device Description
PLASMA IQ 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 316L stainless steel is available with the system. The handheld device is cordless and is charged in a docking/charging station prior to use.
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K Number
K192813Device Name
Plasma IQ
Manufacturer
Neauvia North America, Inc
Date Cleared
2020-03-06
(157 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
Neauvia North America, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Plasma IQ is used in the removal and destruction of skin lesions and coagulation of tissue.
Device Description
PLASMA IQ 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 316L stainless steel is available with the system. The handheld device is cordless and is charged in a docking/charging station prior to use.
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