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510(k) Data Aggregation

    K Number
    K222226
    Device Name
    EON
    Manufacturer
    Dominion Aesthetic Technologies, Inc.
    Date Cleared
    2023-02-17

    (207 days)

    Product Code
    PKT
    Regulation Number
    878.5400
    Why did this record match?
    Applicant Name (Manufacturer) :

    Dominion Aesthetic Technologies, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EON (1064nm laser) is intended for non-invasive lipolysis of the abdomen, flanks, back, and thighs to achieve disruption of adipocyte cells intended for non-invasive aesthetic use to achieve a desired aesthetic effect. It is intended for individuals with a Body Mass Index of 30 or less.
    Device Description
    EON aesthetic laser system is 1064nm diode laser device that is intended for non-invasive lipolysis of the abdomen, flanks, back, and thighs in individuals with a Body Mass Index (BMI) of 30 or less. This wavelength is used to affect the appearance of visible fat bulges in the abdomen and flanks. Both laser energy and cooling air are delivered concurrently through the same treatment head that is positioned and moved over the skin at a fixed height by a robotic arm. The treatment head is never in contact with the skin. During treatment, the desired area will be defined by the physician and will be treated with the 1064nm laser over a 20-minute timeframe. The mechanism of action is to preferentially heat the adipose tissue to temperatures that will induce apoptosis (>42°C). The cooling system will maintain the skin at comfortable temperature (<43°C).
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    K Number
    K211681
    Device Name
    EON
    Manufacturer
    Dominion Aesthetic Technologies, Inc.
    Date Cleared
    2022-03-30

    (302 days)

    Product Code
    PKT, GEX, OOK
    Regulation Number
    878.5400
    Why did this record match?
    Applicant Name (Manufacturer) :

    Dominion Aesthetic Technologies, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EON (1064nm laser) is intended for non-invasive lipolysis of the abdomen and flanks to achieve disruption of adipocyte cells intended for non-invasive aesthetic use to achieve a desired aesthetic effect. It is intended for individuals with a Body Mass Index of 30 or less.
    Device Description
    EON aesthetic laser system is 1064nm diode laser device that is intended for non-invasive lipolysis of the abdomen and flanks in individuals with a Body Mass Index (BMI) of 30 or less. This wavelength is used to affect the appearance of visible fat bulges in the abdomen and flanks. Both laser energy and cooling air are delivered concurrently through the same treatment head that is positioned by a robotic arm. The treatment head is never in contact with the skin. During treatment, the desired area will be defined by the physician and will be treated with the 1064nm laser over a 20-minute timeframe. The mechanism of action is to preferentially heat the adipose tissue to temperatures that will induce apoptosis (42°C to 50°C). The cooling system will maintain the skin at comfortable temperature (<43°C).
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    K Number
    K180511
    Device Name
    Eon FR
    Manufacturer
    Dominion Aesthetic Technologies, Inc.
    Date Cleared
    2019-06-12

    (470 days)

    Product Code
    PKT, GEX, PXT
    Regulation Number
    878.5400
    Why did this record match?
    Applicant Name (Manufacturer) :

    Dominion Aesthetic Technologies, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The eon™ FR (1064nm laser) is intended for non-invasive lipolysis of the abdomen to achieve disruption of adipocyte cells intended for non-invasive aesthetic use to achieve a desired aesthetic effect. It is intended for individuals with a Body Mass Index (BMI) of 30 or less.
    Device Description
    Not Found
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