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The Optimas MAX System with the Diolaze XL MAX is intended for hair removal and permanent hair reduction defined as the stable, long-term reduction in hair counts at 6, 9, or 12 months following a treatment regime. The Fusion Light and the Fusion Dark are intended for hair removal. The Optimas MAX System with the VasculazeMAX is intended for the treatment of vascular lesions, including angiomas, hemangiomas, telangiectasia, port wine stains, leg veins and other benign vascular lesions. The Optimas MAX System with the Lumecca Peak Applicators are indicated for use for the following treatments: - The treatment of benign pigmented epidermal lesions, including dyschromia, hyperpigmentation, melasma, ephelides (freckles); - The treatment of benign cutaneous vascular lesions, including port wine stains, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, superficial leg veins and venous malformations. The Optimas MAX System with the Plus and Forma Handpieces are indicated for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation The Optimas MAX System with the he Morpheus8 Applicators is intended for use in dermatologic procedures where coagulation/contraction of soft tissue or hemostasis is needed. At higher energy levels greater than 62 mJ/pin, the use of the Morpheus8 Applicator is limited to Skin Types I-IV.

The Optimas MAX system is a computerized, versatile system that generates Laser, IPL, and RF energies for the treatment of several clinical indications. The device utilizes different applicators to achieve its mode of operation in accordance with the selected technology and clinical indication. The device system operates when any of the applicators are connected and enables individual adjustment of treatment parameters. The water-cooling system provides cooling for laser and IPL applicators and thermoelectric coolers (TECs). The cooling system includes a radiator, water pump, fan, water reservoir, deionizer, water filter, tissue contact temperature sensor, and water flow sensor. The system is compatible with the following applicators: - DIOLAZE XL 810, 810/1064 and 755/810 (previously cleared as DIOLAZE XL) - LUMECCA 515 PEAK and LUMECCA 580 PEAK (previously cleared as LUMECCA) - VASCULAZE 1064 (previously cleared as Vasculaze) - FORMA (previously cleared as Forma (Plus)) - PLUS (previously cleared as Plus/Plus) - MORPHEUS8 - MORPHEUS8 DEEP (previously cleared in K231790 as MORPHEUS8 Body)

The DEFINE System with the non-invasive applicators employs RF energy for various applications: The DEFINE System with the 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 DEFINE System with the FORMA Applicator is intended for the relief of minor muscle aches and pain. relief of muscle spasm. and for the temporary improvement of local blood circulation. The DEFINE System with the MiniFX Applicator is intended for the relief of minor muscle aches and pain, relief of muscle spasm, for the temporary improvement of local blood circulation and for the temporary reduction in the appearance of cellulite. The DEFINE System with the Morpheus8 Applicator is intended for use in dermatologic procedures where coagulation/contraction of soft tissue or hemostasis is needed. At higher energy levels greater than 62 mJ/pin, the use of the Morpheus8 Applicator is limited to Skin Types I-IV.

The DEFINE device is designed to deliver non-thermal RF energy to the skin and subdermal fat. The RF energy is transmitted to the Applicators and delivered to the treatment area throughout the set of RF electrodes positioned on the treatment units. The invested RF energy is transformed into local heating of the treatment area. Local heating of the skin and underlying tissue layers temporarily ease the symptoms of muscle aches, pain & spasm. It also contributes to the temporary improvement of local blood circulation. The DEFINE device platform comprises a AC/DC power supply unit, main controller, two RF generators, distributor card and user interface including a touch screen. The system platform contains four designated connectors for the following applicators: - Cheek Applicator (hands-free) ● - Chin Applicator (hands-free) ● - FORMA Applicator ● - MiniFX ● - MORPHEUS8 Applicator with the resurfacing, 12 and 24 pin tip heads ● The DEFINE device RF 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 or by a foot pedal. The DEFINE device incorporates a treatment deactivation button. Pressing the deactivation button by either the patient or caregiver would immediately halt the treatment and switch the device into a Pause mode until the operator re-enables it.

The InMode RF System is indicated for use in dermatological and general surgical procedures where coagulation/contraction of soft tissue or hemostasis is needed.

The InMode RF System is a computerized system generating RF energy with integral temperature and impedance feedback mechanism for procedures requiring electrocoagulation/contraction of soft tissue 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 handpiece is connected to the console via a cable and a foot switch activates the energy delivery to the handpiece. Multiple handpieces are available, all comprised of a disposable, single use plastic handle with active internal electrodes. A subset of handpieces have both internal (active) and external (return) electrodes.

The InMode System with the Morpheus8 90 Applicator is intended for use in dermatological procedures where coaqulation/contraction of soft tissue or hemostasis is needed. At higher energy levels greater than 62 mJ/pin, the use of the Morpheus8 90 Applicator is limited to Skin Types I-IV.

The InMode System with the Morpheus8 90 Applicator is a RF technology based device intended for dermatological applications which require coagulation/contraction of soft tissue or hemostasis. The device platform is identical to the one in FDA-Cleared InMode System with the Fractora3D 90 Applicator (K180189), inclusive of minor software modifications. The InMode System with the Morpheus8 90 Applicator employs fractional RF multi-electrode technology for procedures requiring electrocoaqulation and hemostasis. The Morpheus8 90 Applicator is deliver radiofrequency energy to the skin in a fractional manner, via an array of multi-electrode pins. The device provides enhanced safety while minimizing possible side effects by monitoring RF parameters. The InMode System with the Morpheus8 90 Applicator consists of an AC/DC power supply unit, RF generator, controller and user interface including LCD touch screen. The Morpheus8 90 Applicator is connected to the console via a cable and a foot switch activates the energy delivery to the applicator. The Morpheus a handle and a detachable, sterilized, disposable, singleuse 24 pin tip head accessory.

The InMode RF System is indicated for use in dermatological and general surgical procedures where coagulation/contraction of soft tissue or hemostasis is needed.

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/contraction of soft tissue 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 handpiece is connected to the console via a cable and a foot switch activates the energy delivery to the hand piece. The handpiece is comprised of a disposable, single use plastic handle with internal and external electrodes.

The Evolve System with the Transform Applicator employs RF technology and EMS-TENS technology for the treatment of selected medical conditions. The Transform Applicator in RF mode 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 Transform Applicator in EMS mode is intended for: - . Relaxation of muscle spasms - . Prevention or retardation of disuse atrophy - . Increasing local blood circulation - Muscle re-education - Maintaining or increasing range of motion ● - Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis ● The Transform Applicator in TENS mode is intended for: - Symptomatic relief and management of chronic, intractable pain - . Post-surgical acute pain - . Post-trauma acute pain Additionally the Transform Applicator in sequential RF/EMS mode is intended for: - . Non-invasive lipolysis (breakdown of fat) of the abdomen. - Reduction in circumference of the abdomen ●

The Evolve System with the Transform Applicator is designed to deliver non-thermal RF energy and electro-muscle and transcutaneous nerve stimulation for the treatment of different body areas for various medical applications. The Evolve System software controls and regulate the different applied energies in accordance with the user system preprograming and treatment settings. The subject device platform system is identical to the FDA-cleared Evolve System platform (K210877). The Evolve System includes the following components: - LCD display touch screen, ● - Audio loudspeaker, - 48V AC/DC power supply, ● - Real time controller, distributor card and 2 RF generators, . - . Fans The System operates while connected to the Transform Applicator. The purpose of this submission is to add non-invasive lipolysis (breakdown of fat) of the abdomen and reduction in circumference of the abdomen to the indications.

The InMode System with the Morpheus8 Applicators is intended for use in dermatologic procedures where coagulation/contraction of soft tissue or hemostasis is needed. At higher energy levels greater than 62 mJ/pin, the use of the Morpheus8 Applicator is limited to Skin Types I-V.

The InMode System with the Morpheus8 Applicators is a RF technology based device intended for dermatological applications which require coagulation/contraction of soft tissue or hemostasis. The device platform is identical to the one in FDA-Cleared InMode System with the Morpheus8 Applicators (K200947), inclusive of minor software modifications, cleared in K210492 and K221571. The InMode System with the Morpheus8 Applicators employs fractional RF multi-electrode technology for procedures requiring electrocoagulation and hemostasis. The Morpheus8 Applicators are designed to deliver radiofrequency energy to the skin in a fractional manner, via an array of multi-electrode pins. The device provides enhanced safety while minimizing possible side effects by monitoring RF parameters. The InMode System with the Morpheus8 Applicators consists of an AC/DC power supply unit, RF generator, controller and user interface including LCD touch screen. The Morpheus8 Applicators are connected to the console via a cable and a foot switch activates the energy delivery to the applicator. The device has two Applicators which can be connected to the platform, one at the time. The Morpheus8 Applicator comprises a handle and detachable, sterilized, disposable, single-use 12, 24, and T tip head accessories. The Morpheus8 Body Applicator is identical except that the compatible tip head is a 40 pin tip head.

The InMode Multi System with the Diode laser Applicators is indicated for: · Diolaze XL 810nm Applicator is intended for hair removal and permanent hair reduction defined as the stable, long-term reduction in hair counts at 6, 9, or 12 months following a treatment regime. · Diolaze XL 755/810nm & 810/1064nm Applicators are intended for hair removal. · VLaze Applicator is intended for the treatment of vascular lesions, including angiomas, hemangiomas, telangiectasia, port wine stains, leg veins and other benign vascular lesions. The InMode Multi System with the IPL Applicator is indicated for: • IPL Applicator with wavelengths (515-1200mm) is indicated for use for the following treatments: The treatment of benign pigmented epidermal lesions, including dyschromia, hyperpigmentation, melasma, The treatment of benign cutaneous vascular lesions, including port wine stains, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikilodenna of Civatte, superficial leg veins and venlous malformations. The InMode Multi System with the non-invasive RF Applicators is indicated for: · BodyFX (WMBody) and MiniFX Applicators are intended for the tollowing medical conditions: Relief of minor muscle aches and pains, relief of muscle spasm, temporary improvement of local blood circulation; and temporary reduction in the appearance of cellulite. · PLUS/ PLUS90/PLUS-PLUS (FORMA) and i-Forma Applicators are indicated for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation. · FaceFX (WMFace) Applicator is intended for use in dermatologic procedures, for noninvasive treatment of mild to moderate facial wrinkles and rhytids. The InMode Multi System with the Fractional RF Applicators is indicated for: · FRACTORA 60 pin Applicator is intended for use in dermatological procedures requiring ablation and resurfacing of the skin. · FRF 24 pin Applicator is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. · Fractora3D and Morpheus8 Applicators are intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. At higher energy levels greater than 62 mJ/pin, use is limited to Skin Types I-V.

The InMode Multi-System supports multiple technological applications and accessories intended for different clinical indications. The subject device is designed to exert finely controlled radiofrequency, laser or IPL energy utilizing different treatment applicators. The subject device comprises a system platform and compatible set of applicators. The system platform was originally FDA Cleared in K180719 and is manufactured by InMode Ltd. The subject device platform sustains additional FDA Cleared applicators, all manufactured by InMode Ltd. The below list comprises the set of applicators to be registered under the subject device: - . Laser Applicators: - o Diolaze XL 810nm - Diolaze XL 755/810nm o - Diolaze XL 810/1064nm o - VLaze (Vasculaze) о - IPL Applicator: ● - o SR IPL (Lumecca 580, Lumecca 515) - Non-Invasive RF Applicators: ● - o Forma (Plus) - Plus (Plus Plus) о - Plus90 o - о i-Forma - BodyFX™ (WMBody) o - MiniFXTM o - WMFace o - Fractional RF Applicators: ● - Fractora o - 24 pins tip (FRF) - - । 60 pins tip - 0 Morpheus8TM - 12 pins tip (Prime Tip) - - 24 pins tip (Fractora 3D) - - 40 pins tip (Body Tip) - - T tip - The platform of the subject device has undergone some slight design modifications, mainly in software, to support the integration of the abovementioned applicators. Slight modifications were also performed on platform hardware for the same purpose. Additionally, the user interface screen was slightly enlarged from 10" to 12".

The Evolve System with the T3 Applicator employs RF technology or EMS-TENS technology for the treatment of selected medical conditions. The T3 Applicator in RF mode 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 T3 Applicator in EMS mode is intended for: - Relaxation of muscle spasms - Prevention or retardation of disuse atrophy - Increasing local blood circulation - Muscle re-education - Maintaining or increasing range of motion - Immediate post surgical stimulation of calf muscles to prevent venous thrombosis The T3 Applicator in TENS mode is intended for: - Symptomatic relief and management of chronic, intractable pain - Post-surgical acute pain - Post-trauma acute pain The RF treatment mode and EMS/TENS mode should not be used in combination or sequentially.

The Evolve System with the T3 Applicator is designed to deliver non-thermal RF energy and electro-muscle and transcutaneous nerve stimulation for the treatment of different body areas for various medical applications. The Evolve System software controls and regulate the different applied energies in accordance with the user system preprograming and treatment settings. The subject device platform system is identical to the FDA-Cleared Evolve System platform (a.k.a EmBody System and the subject of K183450). The same platform system was recently FDA-Cleared for the use with the Tone Applicator (subject of K201285). The Evolve System supports the placement of the following components: - LCD display touch screen, - Audio loudspeaker, - 48V AC/DC power supply, - Real time controller, distributor card and 2 RF generators, - Fans The System operates while connected to the T3 Applicator.

The EVOLVE System with the Tone Applicator is an electro-muscle and transcutaneous nerve stimulation device for the treatment of different body areas. The EVOLVE System with Tone Applicator is designed to operate in two modes - EMS and TENS. In EMS mode it is used for: - Relaxation of muscle spasms - Prevention or retardation of disuse atrophy - Increasing local blood circulation - Muscle re-education - Maintaining or increasing range of motion - Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis And in TENS mode is intended for - Symptomatic relief and management of chronic, intractable pain - Post-surgical acute pain - Post-trauma acute pain

The EVOLVE System in combination with Tone Applicator (manufactured by InMode Ltd.), is a computerized device intended to employ EMS (Electrical Muscle Stimulation) and TENS (Transcutaneous Electrical Nerve Stimulation) technologies for various medical applications. The EVOLVE System with the Tone Applicator consists of an AC/DC power supply unit, controller and user interface including an LCD touch screen. The Tone Applicator is connected to the console via a cable, each of the subject device applicator units consist of a designated cable and of a connection port to be directly connected to one of the four connectors positioned on the rear side of the console. Up to four Tone Applicator units can be connected to the console simultaneously. The delivery of the electrical energy is controlled by a Start/Stop button positioned on the LCD screen. The System supports the following components: - LCD display touch screen . - Audio loudspeaker ● - . 48V AC/DC power supply - Controller - . Fans The System operates while connected to the Tone Applicator.