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510(k) Data Aggregation
K Number
K230077Device Name
LaserME
Manufacturer
Date Cleared
2023-07-17
(188 days)
Product Code
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Neauvia North America
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The LaserMe is intended for use in dermatological procedures requiring coagulation of soft tissue and skin resurfacing procedures. The LaserMe is further indicated for treatment of benign pigmented lesions, such as, but not limited to lentigines (age spots), solar lentigos (sun spots), melasma, dyschromia, and for treatment of facial wrinkles and fine lines.
Device Description
LaserME is a non-ablative diode laser. The device is equipped with a diode laser with a wavelength of 1470 nm and a maximum power of 2W, intended for nonablative skin resurfacing. The device works by punctuating the skin (epidermis) with several micro laser beams. The points are evenly spaced with adjustable spacing from 1mm to 4mm. The energy delivered to a single point is regulated from 5mJ to 50mJ.
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K Number
K223222Device Name
Plasma IQ
Manufacturer
Date Cleared
2023-01-17
(92 days)
Product Code
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
Neauvia North America, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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
K213261Device Name
EpilME
Manufacturer
Date Cleared
2022-06-02
(245 days)
Product Code
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Neauvia North America
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Laser EpilME with EpilME applicator is indicated for use in surgical and aesthetic applications in the medical specialties of general and plastic surgery, and dermatology.
The EpilME is intended for use on all skin types (Fitzpatrick skin types I - VI), including tanned skin.
The EpilMe with EpilME Applicator is intended for:
- · Treatment of benign vascular lesions, including angiomas, telangiectasia and other benign vascular lesions and leg veins
- · Treatment of pseudofolliculitis barbae (PFB)
- · Hair removal, permanent hair reduction *
- · Treatment of benign pigmented lesions
*Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regime.
Device Description
The Laser EpilME with EpilME applicator is an electro-optical device consisting of a laser console and applicator. The laser console provides a graphical user interface and software for control of the system, the needed electronics to control and power the accessories, handpiece connection port and cooling system.
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K Number
K212329Device Name
Plasma IQ
Manufacturer
Date Cleared
2021-12-09
(135 days)
Product Code
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
Neauvia North America, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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
K202780Device Name
Sectum
Manufacturer
Date Cleared
2021-07-30
(311 days)
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
Neauvia North America
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Sectum control unit is a high frequency generator intended to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions, such and muscle spasms, increase in local circulation and provide a temporary reduction in the appearance of cellulite. The Sectum control unit utilizes a BODY and PRECISION applicator for delivering high frequency electrotherapy to tissue.
Device Description
The Sectum control unit is a radiofrequency energy generator employed for a variety of aesthetic applications. The control unit output is set and monitored via touchscreen and controlled by foot switch. The control unit can be used with corded bipolar Precision and Body applicators.
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K Number
K192813Device Name
Plasma IQ
Manufacturer
Date Cleared
2020-03-06
(157 days)
Product Code
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
Neauvia North America, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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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