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The BTL-785NEH device has the following indications for use:

The BTL-785NEH with BTL-785-1 applicator is intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The BTL-785-1-4 massage device is intended to provide a temporary reduction in the appearance of cellulite.

The BTL-785NEH with BTL-785-2 applicator is intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation.

The BTL-785NEH with BTL-785-3 applicator is intended to provide heating for the purpose of elevating tissue temperature, for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation.

The BTL-785NEH with BTL-785-4 applicator used with tips BTL-785-4-5 and BTL-785-4-6 is intended for use in dermatological and general surgical procedures for electrocoagulation and hemostasis.

The BTL-785NEH with BTL-785-4 applicator used with tips BTL-785-4-3 and BTL-785-4-4 is intended for dermatological procedures requiring fractional treatment of the skin.

At higher energy levels greater than 62 mJ/pin or microneedle, the use of the BTL-785-4 applicator is limited to Skin Types I-IV.

The BTL-785NEH with BTL-785-7 Handpiece used with hands-free applicators:

BTL-785-7-1 & BTL-785-7-7, BTL-785-7-2 & BTL-785-7-8, BTL-785-7-10, BTL-785-7-11 single-use applicators are intended to provide:

• Heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation.

BTL-785-7-1 & BTL-785-7-2 single-use applicators are intended to provide:

• Non-invasive temporary reduction of facial wrinkles.

BTL-785-7-9 single-use applicator is intended to:

• Affect the appearance of lax tissue in the submental area.

The BTL-785NEH is a state-of-the-art radiofrequency, ultrasound and electrostimulation platform. The device is comprised of a control unit and applicators. The control unit of the system is equipped with a large color touch screen that facilitates the use of the device. The on-screen information guides the user step-by-step through the entire therapy procedure. The device is accompanied by the following applicators:

• BTL-785-1 applicator providing treatment by integration of radiofrequency, ultrasound and active cooling. Suitable for the treatment of large body areas.

• BTL-785-2 applicator providing treatment by integration of radiofrequency and ultrasound. Suitable for the treatment of small areas.

• BTL-785-3 applicator providing radiofrequency treatment. The therapy is provided with single use tips only.

• BTL-785-4 applicator delivering radiofrequency via an array of microneedles and/or superficial pins. Therapy is provided with single use tips only.

• BTL-785-7 handpiece with hands-free applicators providing treatment by integration of radiofrequency heating and muscle stimulation resulting in induced muscle workout. Muscle workout naturally increases local blood circulation. Suitable for the treatment of face, neck and small and sensitive areas. The therapy is provided with single use electrodes only.

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