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The AI.ME™system is indicated for fractional skin resurfacing.

The AI.ME system is a micro coring device controlled by a robot that removes skin by using a disposable punch assembly containing six (6), hollow needle punches inserted into the skin with a fixed maximum penetration depth of 3 mm to remove up to 10% of skin in the treatment area to excise and/or resurface skin. The AI.ME system, which is similar in design and performance as the FDA cleared Venus Concept ARTAS system, consists of a cart, a coring mechanism, single-use vacuum assembly and a sterile single-use disposable punch assembly.

The Venus BlissMAX device is a diode laser system intended for non-invasive lipolysis of the abdomen, flanks, back, and thighs in individuals with a Body Mass Index (BMI) of 30 or less. In addition, the Venus BlissMAX device is intended for the treatment of the following medical conditions; using the MP2 applicator for delivery of RF energy 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 In addition, The Venus BlissMAX device using the FlexMAX applicators is intended for muscle conditioning to stimulate healthy muscles. The Venus BlissMAX device using the FlexMAX applicators is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. The Venus BlissMAX device using the FlexMAX applicators is intended to be operated by a trained professional.

The Venus BlissMAX device is a computerized system comprised of a system console (main unit), four (4) Diode Laser applicators, one (1) MP2 (RF+ PEMF+ Vacuum) applicator and four (4) FlexMAX (EMS) applicators. The system delivers laser, bipolar RF and biphasic electrical energies, vacuum pressure, and pulsed electromagnetic fields (PEMF) to the skin and the underlying tissues of the treatment area. The device provides individual adjustment of laser power, EMS intensity level, and RF power, in addition to vacuum levels, for each patient. The console of the Venus BlissMAX device contains a power supply unit, Laser, RF, and EMS controllers, (power modules, on main board), a suction module (vacuum), a controller unit (on main board), Laser water cooling system (power module, on main board), a touch- screen user interface and display panel. The applicators are connected to the console via a cable. The RF applicator is comprised of various combinations of RF electrodes, magnetic coils, and vacuum conduits. The Laser applicators are comprised of a light guide, touch sensors and light-emitting diodes. The EMS applicator is comprised of two electrodes and a light indicator.

The Venus BlissMAX device is a diode laser system intended for non-invasive lipolysis of the abdomen and flanks in individuals with a Body Mass Index (BMI) of 30 or less. In addition, the Venus BlissMAX device is intended for the treatment of the following medical conditions; using the MP2 applicator for delivery of RF energy 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 In addition, The Venus BlissMAX device using the FlexMAX applicators is intended for muscle conditioning to stimulate healthy muscles. The Venus BlissMAX device using the FlexMAX applicators is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. The Venus BlissMAX device using the FlexMAX applicators is intended to be operated by a trained professional.

The Venus BlissMAX device is a computerized system comprised of a system console (main unit), four (4) Diode Laser applicators, one (1) MP2 (RF+ PEMF+ Vacuum) applicator and four (4) FlexMAX (EMS) applicators. The system delivers laser, bipolar RF and biphasic electrical energies, vacuum pressure, and pulsed electromagnetic fields (PEMF) to the skin and the underlying tissues of the treatment area. The device provides individual adjustment of laser power, EMS intensity level, and RF power, in addition to vacuum levels, for each patient. The console of the Venus BlissMAX device contains a power supply unit, Laser, RF, and EMS controllers, (power modules, on main board), a suction module (vacuum), a controller unit (on main board), Laser water cooling system (power module, on main board), a touch- screen user interface and display panel. The applicators are connected to the console via a cable. The RF applicator is comprised of various combinations of RF electrodes, magnetic coils, and vacuum conduits. The Laser applicators are comprised of a light guide, touch sensors and light-emitting diodes. The EMS applicator is comprised of two electrodes and a light indicator.

The Venus Freedom device is intended for the treatment of the following medical conditions; using the Pearl, Diamond and Slim 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 Freedom device, part of the Family of Venus RF devices, is a noninvasive, non-ablative device that delivers Radiofrequency (RF) energy, along with the Pulsed Electro-Magnetic Field (PEMF), into the skin to generate heat through electrical impedance in the epidermis, dermis, subcutaneous layers, and muscular tissue. The device consists of a console (main unit) and three applicators (Pearl, Diamond and Slim). The Venus Freedom RF energy, PEMF and tissue manipulation (massage), are utilized to trigger changes in the tissue which result in local blood circulation improvement, muscle spasm relief along with pain relief. Temporary reduction in the appearance of cellulite is similarly achieved by the combination of these three main mechanisms: tissue manipulation (massage), RF delivery and PEMF delivery.

The Venus Viva MD™ is a non-invasive device intended to be used by aesthetic-related physicians or dermatologists. - When used with the Viva MD applicator, the Venus Viva MD™ device is intended for use in dermatological procedures requiring ablation and resurfacing of the skin. - When used with the Diamondpolar applicator, the Venus Viva MD™ device is intended for use in dermatological and surgical procedures for females for the non-invasive treatment of moderate to severe facial wrinkles and rhytides in Fitzpatrick skin type I-IV.

The Venus Viva MD™ device consists of a console (main unit) and two applicators: Viva MD applicator and Diamondpolar applicator. The console contains a power supply unit, RF generator (power module, on main board), PMF generator, a controller unit (on main board), a touchscreen user interface and display panel. The Venus Viva MD™ device is a combination of the previously cleared Venus Viva SR (K150161), the primary predicate, and the Diamondpolar applicator that was previously cleared for the secondary predicate Venus Legacy BX (K142910). Both, the Viva MD and Diamondpolar applicators can now be connected simultaneously to a single console, the Venus Viva MD™ console. Additionally, the Viva MD applicator is supplied with single use detachable tips with 80- or 160-electrode pins. The 160-pin tip was previously cleared within Venus Viva SR (K150161).

The Venus Epileve is intended for all Fitzpatrick skin types, including tanned skin, for use in dermatology, general and plastic surgery applications for: - · Hair removal: - 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 Epileve device consists of a tabletop console (main unit) and one detachable diode laser applicator. The system console is the main enclosure that holds and contains all external and internal system components: a power supply unit, laser diode driver, controller unit, and touch screen with LCD display. The console incorporates a water cooling system with a pump in order to constantly keep the tip of the applicator, light guide, chilled. The detachable diode laser applicator is connected to the system via a cable passed through the applicator connectors located in the designated compartment on the system's rear side. When not in use, the applicator can be secured within the applicator cradle on the top panel of the console. The applicator delivers the laser energy to a patient's skin through the applicator's tip made of a sapphire light guide framed in aluminum anodized shells. The applicator is supplied with only one spot size light guide. The device also comes with a footswitch, goggles, patient eye protectors, and water filling kit.

The Venus Viva™ Device is a non-invasive device intended to be used by aesthetic physicians or dermatologists. When used with the Diamondpolar applicator, the Venus Viva™ Device is intended for use in dermatological and surgical procedures for the non-invasive treatment of moderate to severe facial wrinkles and rhytides in Fitzpatrick skin type I-IV. When used with the Viva applicator, the Venus Viva™ Device is intended for use in dermatological procedures requiring ablation and resurfacing of the skin.

The Venus Viva™ device consists of a console (main unit) and two applicators – Viva and Diamondpolar. The console contains a power supply unit, an RF generator (power module, on main board), a controller unit (on main board) and a touchscreen user interface and display panel. The Venus Viva™ device is a combination of the previously cleared Venus Viva™ SR (K150161), the primary predicate, and the Diamondpolar applicator that was previously cleared for the secondary predicate Venus Legacy BX (K142910). Both the Viva and Diamondpolar applicators can now be connected simultaneously to a single console, the Venus Viva™ console.

When used with the Octipolar (LB1) or Diamondpolar (LF1) applicators, the Venus Legacy Pro device is 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. When used with the 4D Body (LB2) or 4D Face (LF2) applicators, the Venus Legacy Pro device is intended for the delivery of non-thermal RF combined with Massage and magnetic field pulses for the treatment of the following medical conditions: - Relief of minor muscles aches and pain, relief of muscle spasm - Temporary improvement of local blood circulation - Temporary reduction in the appearance of cellulite

The Venus Legacy Pro device consists of a console (main unit) and four applicators - Octipolar (LB1), Diamondpolar (LF1), 4D Body (LB2) and 4D Face (LF2). The console 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 Pro device combines two previously cleared devices (Legacy BX, K142910 and Legacy CX. K143554) into one device. The two applicators that were cleared for the Legacy BX Device - Octipolar (LB1) and Diamondpolar (LF1) and the two applicators that were cleared for the Legacy CX device - 4D Body (LB2) and 4D Face (LF2) can now be connected simultaneously to a single console, the Legacy Pro device's console.

The Venus Bliss device is a diode laser system intended for non-invasive lipolysis of the abdomen and flanks in individuals with a Body Mass Index (BMI) of 30 or less. In addition, the Venus Bliss device is intended for the treatment of the following medical conditions; using the MPapplicator for delivery of RF energy 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 Bliss device consists of a console (main unit), one RF applicator and four Diode Laser applicators. The system delivers laser (Diode Laser Applicators) and bipolar RF energies, vacuum pressure, and pulsed magnetic fields (PMF) to the skin (MP2 applicator) and the underlying tissues of the treatment area. The console of the Venus Bliss device contains a power supply unit, Laser and RF controllers, (power modules, on main board), a suction module (vacuum), a controller unit (on main board), Laser water cooling system (power module, on main board), a touch- screen user interface and display panel.

The Venus Heal device is intended for the treatment of the following medical conditions; using the Large and Small 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 subject device Venus Heal system is a modification of the legally marketed Venus Legacy CX system cleared under K143554. The proposed system is a smaller and lightweight version of the previously cleared Venus Legacy CX system. The Venus Heal system consists of a console (main unit) and two applicators (Large and Small). The console design change is driven to enhance the ergonomic capabilities of the product family. The additional changes are summarized below: a) Ergonomics of the user interface: bigger Liquid Crystal Display (LCD) color touch screen. c) Tissue manipulation includes manual massage only. d) Increase of Maximal RF output power. e) Updated software to reflect hardware changes. The Venus Heal RF energy, pulsed magnetic fields (PMF) and tissue manipulation are utilized to trigger changes in the tissue which result in muscle spasm relief and pain relief, along with local blood circulation improvement. Temporary reduction in the appearance of cellulite is similarly achieved by combination of these three main mechanisms: RF and Pulse Magnetic Field (PMF) delivery as well as tissue manipulation, Consistent with the previous clearance, the system is intended to be used in professional healthcare facilities (prescription use) just as the predicate, and its major components are still the main console unit, and individual modules/hand pieces.