Search Results

The InMode RF Pro System with the Non-invasive Applicators employs RF energy for various applications: • i-Forma (Plus), Plus (Plus Plus) and Plus90 for relief of minor muscle aches and pain, relief of muscle spasm, and temporary improvement of local blood circulation. · WMface is intended for use in dermatologic procedures for non-invasive treatment of mild to moderate facial wrinkles and rhytids. · BodyFX™ (WMBody)/MiniFX™ for Relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation and temporary reduction in the appearance of cellulite. The InMode RF Pro System with the Fractional Applicators employs RF energy for various applications: · Fractora Applicator with 60 pins tip is designed for use in dermatological procedures requiring ablation and resurfacing of the skin. · Fractora Applicator with 24 pins tip is intended for use in dermatological and general surgical procedures for electrocoagulation and hemostasis. At higher energy levels greater than 62m.J/pin, use of the applicator is limited to skin types I-IV · Morpheus8™ for dermatological and general surgical procedures for electrocoagulation and hemostasis. At higher energy levels greater than 62mJ/pin, use of the applicator is limited to skin types I-IV

The InMode RF Pro System supports multiple radiofrequency (RF) applications and accessories. The InMode RF Pro System is compatible with the Fractional RF Applicators and the Non-Invasive RF Applicators, and employs RF energy for various applications. The InMode RF Pro System consists of platform console with an AC/DC power supply unit, two applicator connectors, RF generator, RF measuring circuit, controller, footswitch and user interface including a touch screen. The RF Applicator is connected to the console via a cable and a footswitch activates the energy delivery to the applicator. The applicators are comprised of a handle and electrodes, and some of them are used with a single-use tip.

The InMode System with the Morpheus8 (Fractora) Applicators is intended for use in Dermatological and General Surgical procedures for Electrocoagulation and Homeostasis. At higher energy levels greater than 62 ml/pin, use of the Morpheus8 (Fractora) Applicators is limited to Skin Types I-V.

The InMode System with the Morpheus8 (Fractora) Applicators is a computerized, programmed, RF technology-based device intended for dermatological applications which requires skin electrocoagulation and hemostasis. The device platform is basically constituted on the same system platform as FDA cleared for the proposed predicate device; The InMode System with the Fractora3D/3D-90 Applicators (K180189). The device applicators employ fractional RF multi-electrode technology for procedures requiring electrocoagulation and hemostasis. The Morphues8 (Fractora) Applicators are designed to deliver radiofrequency energy to the skin in a fractional manner, via an array of multielectrode pins. The Device provides enhanced safety while minimizing possible side effects by monitoring RF parameters. The InMode System with the Morpheus8 (Fractora) Applicators consists of an AC/DC power supply unit, RF generator, controller and user interface including LCD touch screen. The Morpheus8 (Fractora) Applicators are connected to the console via a cable and a foot switch activates the energy delivery to the applicator. The subject device applicator comprises a disposable, single use, fractional RF electrode pins tip head. The InMode System with the Morpheus8 (Fractora) Applicators comprises the following applicator tip heads: - Morpheus8 24 Pin Applicator (Fractora3D) tip (FDA Cleared in K180189) - Morpheus8 40 Pin treatment tip (New tip) . - . Morpheus8 12 Pin treatment tip (New tip) - . Morpheus8 T Pin treatment tip (New tip)

The EmFace Device with Cheek and Chin Applicators is indicated for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation.

The EmFace Device with the Cheek and Chin Applicators is a hands-free, easy to operate system, designed to deliver non-thermal RF energy to the skin and subdermal fat. The RF power levels used by the device can be adjusted from 10 to 50 Watts and the maximum skin temperature cutoff can be adjusted from 35℃ to a maximum of 43℃. The hands-free applicators multiple RF units are sequentially activated over the treatment area. This ensures homogenous and safe heating distribution over the entire treatment area. The EmFace Device consists of an AC/DC power supply unit, two RF generators, controller and user interface including an LCD touch screen. The System RF non-invasive Applicators are connected to the console via a cable. The delivery of the RF Energy is controlled by a Start/Stop button on the LCD screen. The System operates while connected to any of the following applicators: - . Chin Applicator (with three sequentially activated units) or; - . Cheek Applicator (with eight sequentially activated units) The applicator is connected to the main console via a designated cable and a connection port. The applicators' units are adjusted to the patient using an adjustable designated belt set.

The InMode EmBody System with its designated hand pieces is intended for the treatment of the following medical conditions; The EmBodyPLUS hand piece is intended for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation. The EmBodyFX Hand piece is intended for the treatment of the following medical conditions using RF combined with massage: · Relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation. · Temporary reduction in the appearance of cellulite.

The EmBody System with the EmBodyFX and EmBodyPlus Applicators is a free hand, easy to operate system, designed to deliver non-thermal RF energy to the skin and subdermal fat. The EmBodyFX Applicator also incorporates a mechanical vacuum skin massaging mechanism. The EmBody System is employing RF technology for various aesthetic applications. The device provides individual adjustment of non-thermal RF power and vacuum pulse duration to achieve maximum efficiency and safety for each patient. The design of the device applicators allows efficient treatment of large tissue surfaces. The EmBody System consists of an AC/DC power supply unit, two RF generators, controller and user interface including an LCD touch screen. The System RF noninvasive applicators are connected to the console via a cable. The delivery of the RF Energy is controlled by a Start/Stop button located on the LCD screen. The EmBody System operates while connected to any of the following Applicators: - . EmBodyFX (Up to Six units connected simultaneously) or; - . EmBodyPlus (Up to Eight units connected simultaneously) Each applicator unit is connected to the main console via a designated cable and a connection port. The applicator units are adjusted to the patient body using a designated belt set.

The InMode RF System is indicated for use in dermatological and general surgical procedures for electro-coagulation and hemostasis

The InMode RF System (InMode MD Ltd.) is a computerized system generating RF energy with integral temperature and impedance feedback mechanism for procedures requiring electrocoagulation and hemostasis. The InMode RF System constantly monitors the temperature and impedance of the target treatment tissue, automatically adjusting energy delivery to maintain effective and safe tissue heating. The InMode RF System consists of an AC/DC power supply unit, RF generator, controller and user interface including touch screen. The RF hand piece is connected to the console via a cable and a foot switch activates the energy delivery to the hand piece. The hand piece is comprised of a disposable, single use; internal and external electrodes. The InMode RF System is compatible with the following hand pieces: - . HP060909A (Non-sterilized) - HP101306A (Non-sterilized/Sterilized) ● - HP172206A (Non-sterilized/Sterilized) . - . HP172246A (Non-sterilized/Sterilized) - HP172248A (Sterilized )

The InMode Diolaze XL System with the Diolaze XL 810mm Hand piece is intended for hair removal and permanent hair reduction defined as the stable, long-term reduction is hair counts at 6, 9 or 12 months following a treatment regimen. The InMode Diolaze XL System with the Diolaze XL 755/810nm & 810/1064nm Hand pieces is intended for hair removal.

The InMode Diolaze XL multisystem (manufactured by InMode MD Ltd.) is a laser based technology platform system utilizing different hand pieces for laser hair removal procedures. The Diolaze XL system was already FDA cleared in K170738 along with its designated Diolaze 810nm hand piece. The InMode Diolaze XL System is designed to deliver optical energy to the skin via a pre-cooled sapphire block. The good optical contact between the sapphire block and skin is achieved by using water based gel. The device provides individual adjustment of light fluence and pulse duration to achieve maximum efficiency and safety for each patient. The handpiece has integrated skin cooling to enhance safety and comfort of the treatment. The InMode Diolaze XL System consists of an AC/DC power supply unit, a diode driver, water cooling system, controller and a touch screen user interface. The diode laser hand piece is connected to the console via a cable and a foot switch activates the energy delivery to the hand piece. The hand piece comprises the InMode Diolaze XL System with 20 diode laser bars stacked vertically. The diode is enclosed to the sapphire light guide. The diode laser produces up to 3000W peak optical power. The InMode Diolaze XL System utilizes three add-ons diode laser hand pieces: Diolaze 810nm Hand piece (FDA cleared in K17078), Diolaze 755/810nm Hand piece, Diolaze 810/1064nm Hand piece.

The InMode System with the Fractora3D/3D-90 Applicators is intended for use in Dermatological and General Surgical procedures for Electrocoagulation and Homeostasis. At higher energy levels greater than 62 m./pin, use of the FRF applicator is limited to Skin Types I-IV.

The InMode System with the Fractora3D/3D-90 Applicators is a computerized, programmed, RF technology based device intended for dermatological applications which requires skin electrocoagulation and hemostasis. The device platform is basically constituted on the same system platform as FDA cleared for InMode FRF Applicator (K151273). The InMode System with the Fractora3D/3D-90 Applicators employs fractional RF multi-electrode technology for procedures requiring electrocoagulation and hemostasis. The Fractora3D/3D-90 Applicators are designed to deliver radiofrequency energy to the skin in a fractional manner, via an array of multielectrode pins. The Device provides enhanced safety while minimizing possible side effects by monitoring RF parameters. The InMode System with the Fractora3D/3D-90 Applicators consists of an AC/DC power supply unit, RF generator, controller and user interface including LCD touch screen. The Fractora3D/3D-90 Applicators are connected to the console via a cable and a foot switch activates the energy delivery to the hand piece. The hand piece comprises a disposable, single use, 24 electrode pins tip.

The InMode VLaze is intended for the treatment of vascular lesions, including angiomas, telangiestasia, port wine stains, leg veins and other benign vascular lesions.

The InMode VLaze device is designed to deliver diode laser energy to the skin via a pre-cooled sapphire block. The good optical contact between the sapphire block and skin is achieved by using water based gel. The device provides individual adjustment of light fluence and pulse duration to achieve maximum efficiency and safety for each patient. The hand piece has integrated skin cooling to enhance safety and comfort of the treatment. The InMode VLaze device consists of an AC/DC power supply unit, a diode driver, water cooling system, controller and a touch screen user interface. The diode laser hand piece is connected to the console via a cable and a foot switch activates the energy delivery to the hand piece. The hand piece comprises the InMode VLaze device laser with linear scanning system, cooled sapphire output window (3 x 4mm2), and electronic shutter. The sapphire light guide is located on the front tip of the hand piece and delivers the laser beam energy to the treated tissue, while cooling the skin. The pair of thermoelectric coolers (TECs) located on both sides of the sapphire block provide cooling to a temperature of 7°C. The hand piece contains a trigger button which starts the laser scan and radiation. Fluence is delivered within the limits of 40 to 300J/cm². The hand piece has a cable that is 170cm long and connects the hand piece to the console via a connector.

The InMode PLUS System with the PLUS/PLUS90/PLUS-PLUS Hand pieces is indicated for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation

The InMode PLUS System delivers RF energy to gradually heat the skin and subcutaneous tissue. The RF power levels used by the device can be adjusted from 10 to 50 Watts and the maximum skin temperature cutoff can be adjusted from 35℃ to a maximum of 42°C. The hand pieces are operated while in continuous movement over the treatment area. This ensures uniform and safe heating of the entire treatment area. Each InMode PLUS hand piece is comprised of the hand piece handle, a cable 250 cm long, and a connector, which connects to the rear connector of the InMode PLUS System. Three InMode PLUS hand pieces are available: - . InMode PLUS hand piece - InMode PLUS90 hand piece - InMode PLUS-PLUS hand piece (

The InMode RF System is indicated for use in dermatological and general surgical procedures for electro-coagulation and hemostasis.

The InMode RF System (InMode MD Ltd.) is a computerized system generating RF energy with integral temperature and impedance feedback mechanism for procedures requiring electrocoagulation and hemostasis. The InMode RF System constantly monitors the temperature and impedance of the target treatment tissue, automatically adjusting energy delivery to maintain effective and safe tissue heating. The InMode RF System consists of an AC/DC power supply unit, RF generator, controller and user interface including touch screen. The RF hand piece is connected to the console via a cable and a foot switch activates the energy delivery to the hand piece. The hand piece is comprised of a disposable, single use; internal and external electrodes. The InMode RF System is compatible with the following hand pieces: - HP101306A (optional sterile/non-sterile) - HP172206A (optional sterile/non-sterile ● - HP172246A (non-sterile) ●