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510(k) Data Aggregation

    K Number
    K240658
    Device Name
    1060nm laser body slimming machine
    Manufacturer
    HeBei JT Medical Co., Ltd.
    Date Cleared
    2024-05-13

    (66 days)

    Product Code
    PKT
    Regulation Number
    878.5400
    Why did this record match?
    Product Code :

    PKT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    1060nm laser body slimming machine 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. The device is intended to affect the appearance of visible fat bulges in the abdomen, flank, back, and thighs.
    Device Description
    The 1060nm laser body slimming machine is an ultra-thermal laser fat decomposition system that uses the latest technology for non-invasive body shaping. It uses 1060mm wavelength laser penetration to target adipose tissue, selectively heats fat cells, and reduces the number of fat cells in the area through blood and lymph metabolism to achieve shaping the purpose of body contouring. It is a new generation of safe and effective way to lose weight.
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    K Number
    K233962
    Device Name
    ReBorn (1050nm)
    Manufacturer
    LightFective Ltd.
    Date Cleared
    2024-04-16

    (123 days)

    Product Code
    PKT
    Regulation Number
    878.5400
    Why did this record match?
    Product Code :

    PKT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ReBorn device is an LED technology-based system intended for non-invasive lipolysis of the abdomen and flanks in individuals with a Body Mass Index (BMI) of 30 or less.
    Device Description
    The ReBorn system is a non-invasive, LED-based system intended for non-invasive lipolysis and indicated for non-invasive lipolysis of the abdomen and flanks. The Lightfective ReBorn System is a Light Emitting Diode (LED) system, generating optical energy at 1050mm. The ReBorn's cooling and electrical systems maintain safe and comfortable skin surface temperatures. The Lightfective ReBorn system delivers power of up to 49 Watts (per each applicator) in continuous wave (CW) mode. The device consists of hardware and software. These elements are integrated in the ReBorn console and applicator/handpiece. The ReBorn system is supplied as a console and 4 identical applicators. The device is portable and was specifically designed to be utilized in clinic environments. The console is floor-standing and portable. It is controlled by a touch screen and consists of the following subsystems: Power Supply, Main Controller unit (CPU), Water cooling system (Chiller), Touchscreen display monitor, System on Module (SOM) and proprietary software, Applicator docking panel (cradle), Four designated applicator connector ports.
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    K Number
    K231971
    Device Name
    DEKA PHYSIQ 360
    Manufacturer
    El.En. S.p.A
    Date Cleared
    2023-09-26

    (85 days)

    Product Code
    PKT
    Regulation Number
    878.5400
    Why did this record match?
    Product Code :

    PKT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DEKA PHYSIQ 360 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. The device is intended to affect the appearance of visible fat bulges in the abdomen, flanks, back, and thighs.
    Device Description
    The PHYSIQ 360 is a diode laser device. The device is provided with: - Up to 4 applicators that deliver the laser energy to the patient (to subcutaneous tissue layers). - An LCD control panel with touch-screen technology provides information on the status and settings of the PHYSIQ 360 device to input commands into the system. - One wavelength, 1060 ±20 nm (infrared) The PHYSIQ 360 electrical specifications are: 115-230V~ single phase, 50/60Hz, 1200VA (max)
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    K Number
    K231131
    Device Name
    Diode Laser Body Sculpture Systems
    Manufacturer
    Shanghai Bele Medical Technology Co.,Ltd
    Date Cleared
    2023-06-22

    (62 days)

    Product Code
    PKT
    Regulation Number
    878.5400
    Why did this record match?
    Product Code :

    PKT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This product 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. The device is intended to affect the appearance of visible fat bulges in the abdomen, flanks, back, and thighs.
    Device Description
    The BL-A10 is a 1060nm Diode Hyperthermic Laser Lipolysis system and is the latest technology for non-invasive body contouring. It applies a 1060nm wavelength laser to target the adipose tissue to reduce fat in areas such as flank and abdomen. The purpose of the device is to breakdown the fat cells in the target area and in doing so contour the body and reduce the number of fat cells in that area. It is designed to meet international safety and performance standards.
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    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?
    Product Code :

    PKT

    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
    K222265
    Device Name
    Diosculpt
    Manufacturer
    Shanghai Wonderful Opto-Electrics Tech. Co., Ltd.
    Date Cleared
    2022-09-23

    (57 days)

    Product Code
    PKT
    Regulation Number
    878.5400
    Why did this record match?
    Product Code :

    PKT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DioSculpt laser system 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.
    Device Description
    The DioSculpt laser lipolysis system is a diode laser system, Electrically efficient semiconductor generate optical radiation (1060nm) which is used to deliver laser energy to subcutaneous tissue layers. DioSculpt's cooling and electical systems assist in maintaining safe and comfortable skin surface temperatures.
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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?
    Product Code :

    PKT

    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
    K212331
    Device Name
    BodySculp
    Manufacturer
    Rohrer Aesthetics, LLC
    Date Cleared
    2021-11-09

    (105 days)

    Product Code
    PKT
    Regulation Number
    878.5400
    Why did this record match?
    Product Code :

    PKT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Bodysculp laser lipolysis system is intended for non-invasive lipolysis of the flank and abdomen to achieve disruption of adipocyte cells intended for non-invasive aesthetic assthetic affect. This treatment is intended for individuals with a Body Mass Index (BMI) of 30 or less.
    Device Description
    The BodySculp is a diode laser system. The main components of BodySculp are a console and four applicators that deliver the laser energy to the patient. Electrically efficient semiconductors generate optical radiation (1060 nm) which issued to deliver laser energy to subcutaneous tissue layers.
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    K Number
    K211402
    Device Name
    Powersculp laser lipolysis system
    Manufacturer
    Lotuxs Medtech (Suzhou) Co., Ltd.
    Date Cleared
    2021-07-30

    (85 days)

    Product Code
    PKT
    Regulation Number
    878.5400
    Why did this record match?
    Product Code :

    PKT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Powersculp laser lipolysis system is intended for non-invasive lipolysis of the flank and abdomen to achieve disruption of adipocyte cells intended for non-invasive a desired aesthetic affect. This treatment is intended for individuals with a Body Mass Index (BMI) of 30 or less.
    Device Description
    PowerSculp laser lipolysis system is a diode laser system that emits laser radiation centered at 1064nm in order to achieve non-invasive laser lipolysis. Main components of the device include the laser console with display and controls, and four cooled laser applicators that attach to frames and a belt that is attached to the person being treated. The device is powered by an alternating current electrical power source.
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    K Number
    K192970
    Device Name
    SLIMUS
    Manufacturer
    HIRONIC Co., Ltd
    Date Cleared
    2020-12-01

    (405 days)

    Product Code
    PKT, ISA
    Regulation Number
    878.5400
    Why did this record match?
    Product Code :

    PKT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SLIMUS 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. The device is intended to affect the appearance of visible fat bulges in the abdomen, flanks, back, and thighs. Vibrator installed inside each hand-piece and operable only in non-laser output condition is intended for relief from minor muscle aches and pains.
    Device Description
    The SLIMUS device incorporates a laser system that emits a 1060 nm wavelength using a diode laser. Laser radiation is emitted from the laser main unit to the device's handpieces through the handpiece fibers. The device is used to noninvasively reduce the size of the waist of overweight patients with a Body Mass Index (BMI) of less than 30 (kg/m²). A vibrator function is installed inside of each hand-piece and operable only in non-laser output mode. The device's handpieces are fixed to a belt which then combined provide mechanical vibration to the patient in order provide relief from minor muscle aches and pains.
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