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510(k) Data Aggregation

    K Number
    K243716
    Device Name
    Zionic Pro Max (Radiofrequency)
    Manufacturer
    TermoSalud S.L.
    Date Cleared
    2025-05-28

    (177 days)

    Product Code
    PBX
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    TermoSalud S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ZIONIC PRO MAX (radiofrequency) equipment when used with the capacitive or resistive handpiece is indicated to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The massage device is intended to provide a temporary reduction in the appearance of cellulite.
    Device Description
    The Zionic Pro Max with Radiofrequency is a non-invasive topical heating device that produces RF energy to warm subcutaneous tissue the therapeutic temperature of 40-45°C. The device includes two different type of RF handpieces, resistive and capacitive, which are connected to a console and software-powered user interface. The Zionic Pro Max adds a new capacitive handpiece and user interface to a previously cleared generation of the device.
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    K Number
    K243488
    Device Name
    VMAT PRO
    Manufacturer
    TermoSalud
    Date Cleared
    2025-02-06

    (86 days)

    Product Code
    ISA
    Regulation Number
    890.5660
    Why did this record match?
    Applicant Name (Manufacturer) :

    TermoSalud

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VMAP PRO is intended for relief of minor muscle aches and pains, temporary increase in local blood circulation and activation of connective tissue.
    Device Description
    The VMAT PRO is a pressure pulse device that creates pneumatically generated pressure pulses caused by compressed air delivering ballistic projectile through a handpiece coming into contact with the skin. VMAT PRO is equipped with one handpieces that includes four transmitters [VAT120 (diameter of 20mm), VAT220 (diameter of 20mm), VAT215 (diameter of 15mm), and VAT 135 (diameter 35mm)] that allow radial treatments, ergonomically designed to allow the user to work in various areas of the body. To facilitate the movement of the transmitter on the skin, and guarantee a correct contact, an ultrasound gel FDA cleared should be used (i.e. Aquasonic 100 Ultrasound Transmission Gel K802146).
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    K Number
    K241656
    Device Name
    Eneka Selectif
    Manufacturer
    TermoSalud
    Date Cleared
    2024-08-12

    (63 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    TermoSalud

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended Use ENEKA SELECTIF is intended for use in dermatologic and general surgical procedures. Indications for Use ENEKA SELECTIF System with 755nm Laser applicator is intended for: - Hair removal with Dynamic and Fast Dynamic (FDHR) modes intended for permanent reduction in hair regrowth, defined as a 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. - Treatment and prevention of Pseudofolliculitis barbae (PFB). - Use on all skin types (Fitzpatrick I-VI). - Treatment of benign pigmented lesions. ENEKA SELECTIF System with 810nm Laser applicator is intended for: - Hair removal with Dynamic and Fast Dynamic (FDHR) modes intended for permanent reduction in hair regrowth, defined as a 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. - Treatment and prevention of Pseudofolliculitis barbae (PFB). - Use on all skin types (Fitzpatrick I-VI). - Treatment of benign pigmented lesions. ENEKA SELECTIF System with 1060nm Laser applicator is intended for: - Hair removal with Dynamic and Fast Dynamic (FDHR) modes intended for permanent reduction in hair regrowth, defined as a 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. - Treatment and prevention of Pseudofolliculitis barbae (PFB). - Use on all skin types (Fitzpatrick I-VI). - Treatment of benign vascular lesions. ENEKA SELECTIF System with 810 - 1060mm Laser applicator is intended for: -Hair removal with Dynamic and Fast Dynamic (FDHR) modes intended for permanent reduction in hair regrowth, defined as a 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. - Treatment and prevention of Pseudofolliculitis barbae (PFB). - Use on all skin types (Fitzpatrick I-VI).
    Device Description
    The ENEKA SELECTIF is a non-invasive diode laser system used for hair removal, prevention and treatment of Pseudofolliculitis barbae and treatment of vascular and pigmented lesions. The system operates at different wavelengths (755, 810 and 1060 nm) separately plus a blended handpiece combining three wavelengths (810, 940 and 1060 nm). The ENEKA SELECTIF is a diode laser device with 7 handpieces (spot sizes 10x9mm, 20x9mm and 30x12mm) and it allows two modes of treatment, DHR and FDHR. Both of them can be applied with every handpiece. Mode DHR allows the configuration of pulse width, frequency and fluency and mode FDHR allows the configuration of frequency and fluency.
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    K Number
    K230659
    Device Name
    Zionic Aesthetic
    Manufacturer
    TermoSalud
    Date Cleared
    2023-06-08

    (91 days)

    Product Code
    PBX
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    TermoSalud

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Zionic Aesthetic is intended to provide topical heating tor the purpose of elevating tissue temperature for treatment of selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The massage device provided is intended to provide a temporary reduction in the appearance of cellulite.
    Device Description
    The ZIONIC ASTHETIC is a resistive radiofrequency device which output energy can reach up to 200W. It has two different electrodes with different sizes, to adapt the treatment to the different body areas. The electrodes roll to perform a massage while applying the radiofrequency energy.
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    K Number
    K230412
    Device Name
    Symmed Elite Aesthetic
    Manufacturer
    TermoSalud
    Date Cleared
    2023-04-13

    (57 days)

    Product Code
    PBX
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    TermoSalud

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Symmed Elite Aesthetic is intended to provide topical heating for the purpose of elevating tissue temperature for treatment of selected medical conditions such as: relief of pain, muscle spasms, increase in local circulation. The massage device provided is intended to provide a temporary reduction in the appearance of cellulite.
    Device Description
    The Symmed Elite Aesthetic device is a radiofrequency generator that is used for a number of pain related applications such as" to relieve pain, muscle spasms and increase local circulation through electrical and thermal stimulation of the treated tissues". In addition, it contains a massage function that provides temporary improvement in the appearance of cellulite. The Symmed Elite Aesthetic consists of a console plus 2 handpieces, each with 3 different size electrodes. Each handpiece is capable of being fitted with the optional massager. This allows for flexible treatment parameters throughout the working range and handpieces.
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    K Number
    K223680
    Device Name
    Eneka Pro
    Manufacturer
    TermoSalud
    Date Cleared
    2023-02-10

    (64 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    TermoSalud

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Indications for use for Eneka Pro diode laser hair removal system with 808nm applicators include: · Hair Removal with Dynamic (DHR) and Fast Dynamic (FDHR) mode intended for permanent reduction in hair regrowth, defined as a 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. - · Treatment of Pseudofolliculitis barbae (PFB). - · Use on all skin types (Fitzpatrick I-VI)
    Device Description
    The Eneka Pro is a non-invasive diode laser based system used for Hair Removal. The system is based on a single wavelength diode laser with 2 handpieces (spot sizes 20x9mm and 34x14mm) and the ability to control the pulse width, frequency and power. The Hair Removal Laser is intended for use on all skin types (Fitzpatrick skin types I-VI).
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