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510(k) Data Aggregation
K Number
K222226Device Name
EON
Manufacturer
Dominion Aesthetic Technologies, Inc.
Date Cleared
2023-02-17
(207 days)
Product Code
PKT
Regulation Number
878.5400Why 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
K211681Device Name
EON
Manufacturer
Dominion Aesthetic Technologies, Inc.
Date Cleared
2022-03-30
(302 days)
Product Code
PKT, GEX, OOK
Regulation Number
878.5400Why 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
K180511Device Name
Eon FR
Manufacturer
Dominion Aesthetic Technologies, Inc.
Date Cleared
2019-06-12
(470 days)
Product Code
PKT, GEX, PXT
Regulation Number
878.5400Why 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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