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The Venus Velocity is intended for all Fitzpatrick skin types, including tanned skin, for use in dermatology, general and plastic surgery applications for: - Hair removal; - o Permanent hair reduction (defined as the long-term stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen); and - . Treatment of pseudofolliculitis barbae.

The Venus Velocity consists of a console, a detachable diode laser applicator, and three interchangeable sapphire light quides/tips (small, medium, and large sizes). A water system and pump in the console distribute water to cool the handpiece and tips during device use, decreasing the likelihood of burns, discomfort, or pain during treatment. The system is also provided with a water filling kit. The device incorporates several safety features, including an emergency laser stop button, user login and password protection, and other software and hardware settings to mitigate the risk of improper energy release and ensure that system outputs are within specifications. The device also comes with goggles and patient eye protectors.

The Venus Versa System is a multi-application device intended to be used in aesthetic procedures. The SR515 and SR580 IPL applicators are indicated for the following: Treatment of benign pigmented epidermal and cutaneous lesions including: hyperpigmentation, melasma, ephelides (freckles), lentigines, nevi, and cafe-au-lait macules. Treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, angiomas, poikiloderma of civatte, leg veins and venous malformations. The HR650, HR690, HR650XL, and HR690XL IPL applicators are indicated for the removal of unwanted hair and to effect stable long-term or permanent hair reduction for skin types I-IV. Permanent hair reduction is defined as the longterm stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen. The Venus Concept ACDUAL applicator is intended to be used for the treatment of acne vulgaris. The Diamondpolar and Octipolar applicators are non-invasive devices intended for use in dermatologic and general surgery procedures for the non-invasive treatment of moderate to severe facial wrinkles and rtides in Fitzpatrick skin types I-IV. The Viva applicator is intended for dermatological procedures requiring ablation and resurfacing of the skin.

The Venus Versa System is comprised of a console (controller/CPU) and ten detachable handpieces (applicators). The system can deliver three types of energies to the patient's skin using the associated applicators: - Intense Pulsed Light (IPL); ● - Radiofrequency (RF); . - Magnetic Pulse (MP2). . The following ten handpieces are included with the device system: SR515, SR580, HR650, HR690, HR650XL, HR690XL, ACDUAL, Diamondpolar, Octipolar, and Viva.

The Venus Versa System is a multi-application device intended to be used in aesthetic procedures. The SR515 and SR580 IPL applicators are indicated for the following: · Treatment of benign pigmented epidermal and cutaneous lesions including: hyperpigmentation, melasma, ephelides (freckles), lentigines, nevi, and cafe-au-lait macules. · Treatment of benign cutaneous vascular lesions including: port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, angiomas, poikiloderma of civatte, leg veins and venous malformations. The HR650 and HR690 IPL applicators are indicated for the removal of unwanted hair and to effect stable long-term or permanent hair reduction for skin types I-IV. Permanent hair reduction is the long-term stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen.

The Venus Versa System is comprised of a console (controller/CPU) and applicators that deliver Intense Pulsed Light (IPL) optical energy to the treatment area. Four IPL handpieces (SR515, SR580, HR650, HR690) are included with the device system. The Versa device provides individual adjustment of light fluency and pulse duration, and has integrated skin cooling features. Using the IPL applicators, the light energy delivered to the patient's skin is used to treat various conditions via the mechanism of selective photothermolysis.

The Venus Legacy CX device is intended for the treatment of the following medical conditions; using the LB2 and LF2 applicators for delivery of non-thermal RF combined with massage and magnetic field pulses: - 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 Venus Legacy CX device consists of a console (main unit) and two applicators (LB2, LF2). The console in the Venus Legacy CX device contains a power supply unit, an RF generator (power module, on main board), a suction module (vacuum), a controller unit (on main board) and a touchscreen user interface and display panel. The Venus Legacy CX device provides RF treatments combined with emitted magnetic fields and vacuum massaging. The Vacuum is mainly used for the massaging of deep tissues by creating mild to deep suction. The vacuum massage contributes to the sub-dermal and adipose tissues shrinkage and improves the contact surface between electrodes and tissue. The RF currents heat the adipose and muscular tissues to trigger tissue level changes leading to temporary reduction in the appearance of cellulite and temporary relief of muscle pain and muscle spasm. The RF heating effect also improves local blood circulation in the sub dermal layers. The PMF assists in achieving treatment effect.

The Venus Viva SR system is intended for dermatological procedures requiring ablation and resurfacing of the skin.

The Venus Viva SR device is designed for non-invasive dermatological procedures requiring ablation and resurfacing of the skin. The system is designed to deliver RF energy to the skin in a fractional manner. The device is comprised of a console and an applicator. The applicator is connected to the system via a cable. The applicator (hand piece) includes a detachable electrode tip that is comprised of an array of small electrode pins. The radiofrequency energy is delivered from each of the tissue, heating the dermal layers beneath the pin with minimal injury to the epidermis layer.

The Venus Swan (MP)2 system is a non-invasive device intended for use in dermatologic and general surgical procedures for the non-invasive treatment of moderate to severe facial wrinkles and rhytides in Fitzpatrick skin types I- IV.

The Venus Swan (MP)2 TM System uses Radiofrequency (RF) energy in (MP)2 technology for treatment. (MP)2 technology is a Multi-Polar array of Bi-Polar RF electrodes together with Pulsed Magnetic Field (PMF). The Venus Swan(MP)2 TM is a modification to the previously cleared Venus Concept's Venus Swan system (K100586). The Venus Swan (MP)2 is a noninvasive, non-ablative device consisting of Main Unit (console) - Touch Screen user interface, RF Power module, Controller unit, and Two optional treatment applicators: Octipolar-MTM applicator for medium sized treatment areas, composed of 8 (1) RF electrodes, 8 electrode coils assembled over the electrodes and a central coil (the RF is emitted through the electrodes. The PMF is generated by the coils), and (2) Diamondpolar™ applicator for small treatment areas, composed of 4 RF electrodes, 4 electrode coils (the RF is emitted through the electrodes. The PMF is generated by the coils).

The Venus Freeze (MP)2 system is a non-invasive device intended for use in dermatologic and general surgical procedures for females for the non-invasive treatment of moderate to severe facial wrinkles and rhytides in Fitzpatrick skin types I- IV.

The Venus Freeze (MP)2 is a noninvasive, non-ablative device consisting of: - Main Unit (console) - Touch Screen user interface - RF Power module - Controller unit - Two treatment applicators: (1) Octipolar™ applicator - for large area treatments, composed of 8 RF electrodes, 8 electrode coils assembled over electrodes and 1 central coil (the RF is emitted through the electrodes. The PMF is generated by the coils). (2) Diamondpolar™ applicator - for small area treatments, composed of 4 RF electrodes, 4 electrode coils (the RF is emitted through the electrodes. The PMF is generated by the coils). Touch screen user interface provides: - Applicator selection (Octipolar™ / Diamondpolar™) - RF Power Output and Treatment Time parameter adjustments to fit individual patient's skin condition and anatomical site treated. - Current treatment parameters display. The RF power module provides RF energy to the selected applicator, producing a 1MHz signal.

The Venus Swan™ is a non-invasive device intended for use in Dermatologic and general surgical procedures for the non-invasive treatment of mild to moderate facial wrinkles and rhytides.

The Venus Swan™ System uses Radiofrequency (RF) energy in (MP)2 technology for treatment. (MP)2 technology is a Multi-Polar array of Bi-Polar RF electrodes. The Venus Swan™ is a modification to the previously cleared Venus Concept's Venus Freeze system (K100586). The Venus Swan™ is a non-invasive system consisting of: - Main Unit (console) - Touch Screen user interface - RF Power module Controller unit Three optional treatment applicators: (1) Octipolar-LTM applicator - for large treatment areas, composed of 8 RF electrodes (2) Octipolar-M™ applicator - for medium sized treatment areas, composed of 8 RF electrodes (3) Diamondpolar™ applicator - for small treatment areas, composed of 4 RF electrodes The system can be connected to two applicators only at a time. The user can choose which applicator to use according to the size of the treatment area. The Touch screen user interface provides: - Applicator selection - RF Power Output and Treatment Time parameter adjustments - Current treatment parameters display. The RF power module provides RF energy to the selected applicator, producing a 1MHz signal.

The Venus Freeze is a non-invasive device intended for use in Dermatologic and general surgical procedures for the non-invasive treatment of mild to moderate facial wrinkles and rhytides.

The Venus Freeze is a noninvasive, non-ablative device consisting of: - Main Unit (console) - Touch Screen user interface - RF Power module - Controller unit - Two treatment applicators: (1) Octipolar M applicator - for large treatment areas, composed of 8 RF electrodes (2) Diamondpolar™ applicator - for small treatment areas, composed of 4 RF electrodes. The Touch Screen user interface allows the selection of treatment parameters (time and power) by pressing on the treatment buttons and displays the current treatments settings. The Controller Unit provides the operational and safety function of the system. Treatment applicators transmit Bi-Polar RF energy in a method that creates an organized Bi-Polar RF energy matrix which produces homogeneous heating in the entire treatment area for maximum safety and efficacy, eliminating the need for pre/post cooling mechanisms. The RF power module provides RF energy to the selected applicator, producing a 1MHz signal.