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UltraSlim DIGITAL is indicated for use as a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist, and thighs. UltraSlim DIGITAL is also indicated for use in dermatology for the treatment of superficial, benign vascular, and pigmented lesions. UltraSmooth DIGITAL is indicated for use as a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist, and thighs. The Massager component is indicated for the temporary reduction in the appearance of cellulite.

UltraSlim® Digital and UltraSmooth® Digital are LED light therapy devices. The UltraSlim Digital uses 625nm red light (UltraSlim Digital), and the UltraSmooth Digital uses 532nm green light (UltraSmooth Digitial). The devices are generally described as pole-mounted and free-standing on a rolling base as shown in the figures below. Both devices, UltraSlim® Digital and UltraSmooth® Digital, continue to share the same design platform, and only differ in the color of the LED light array. The associated branding/names, warning labels, and differences due to their respective indications for use will remain the same as previously cleared, and do not change as a result of this proposed controller change. All design and manufacturing parameters are very similar in both devices including the power supply, drivers, internal components, physical form, and control. The devices consist of a main control unit, LED panel, and cable connections. The main control unit contains the main input, fuses, power supply, control circuits, and Minutes selector switch. The power switch has a failsafe system that ensures the voltage from a wall socket can never come in contact with the user. A hospital-approved isolation transformer is mounted on the base of the medical pole cart whose low center of gravity also supports the main control unit and the light fixture from tipping. The console is mounted to the pole with an articulated arm. Treatment time is selected from pre-determined options programmed into the digital timer relay that do not allow the user to vary treatment times. System operation is preset. Both units operate at a frequency of 50Hz – 60Hz and a total power output of 300 W. A design change was implemented, in an identical way, in the control of both devices that changes the unit from manual control to WiFi control. In general terms, the design change effectively replaces the electronic relay from the old design with a WiFi relay switch that is activated via WiFi from a mobile, desktop, tablet, or laptop device. The new control design centers around replacing the manual time interval select and start button with a 4-Channel WiFi Relay Switch. Initiating a start sequence of the unit will be performed via internet control using a Relay Switch that receives its instructions from the user through WiFi control. Users continue to be restricted to the treatment time options of 8 and 20 minutes in the web app, and are able to start the device from the WiFi control. The push button momentary start switch is removed in the new design. Users only have the ability to start the device by way of WiFi control. The devices with the new design change do not contain any software. However, a web app accessible through the internet allows users to log in, select treatment time options of 8 minutes or 20 minutes, and to initiate treatment. The built-in timer control via the 4-Channel WiFi Relay Switch automatically stops the treatment at the end of the approved treatment time based upon the input received from the user. Each device has a unique local IP address that is associated with its assigned router. Each router has its own unique client's ISP-assigned Static IP and may be controlled by WiFi from any phone, tablet, or computer with Internet access.

Cellulize® is indicated for use as a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist, and thighs. The Massager component is indicated for the temporary reduction in the appearance of cellulite.

The Cellulize is a non-invasive green light system with a power output of 105mW/cm2, consisting of 150 light emitting diodes (LEDs) that emit visible light at nominal wavelength of 532nm ± 3nm (visible green light spectrum) and a spectral bandwidth of 10nm. Cellulize® is indicated for use as a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist, and thighs. The Massager component is indicated for the temporary reduction in the appearance of cellulite. The components of the device include a mobile pole cart, controller console which plugs into a hospital-grade isolation transformer (attached with a bracket clamp to the pole cart), LED array mounted on an articulated arm (attached with a bracket clamp to the mobile pole cart), digital timer pre-selected for 8-minutes or 20-minutes, on/off switch, and a hospital-grade power cable. The articulated arm allows the light fixture to be positioned in a wide variety of functional positions. The knuckles and joints on the arm allow the light fixture to be rotated, tilted, and raised/lowered independently. The timer is set to a preset value of 8 minutes for circumference reduction treatment via a validated internal timer delay relay. The light fixture is positioned 17cm (6.8″) from the patient's skin to deliver the standard dose output intensity of 105mW/cm-and standard energy dose of 50 J/cm² with 8 minutes. Cellulize does not use any software.

Photonica Professional is indicated for use as a non-invasive dermatological aesthetic treatment of circumference of hips, waist, and thighs. Photonica Professional is also indicated for use in dermatology for the treatment of superficial, benign vascular, and pigmented lesions.

The Photonica Professional ("Photonica") is a non-invasive red light system with a power output of 105mW/cm2, consisting of 150 light emitting diodes (LEDs) that emit visible light at nominal wavelength of 635nm ± 2nm (visible red light spectrum) and a spectral bandwidth of 10nm. Photonica Professional is indicated for use as a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist, and thighs. Photonica Professional is also indicated for use in dermatology for the treatment of superficial, benign vascular, and pigmented lesions. Photonica Professional was previously cleared (K150336), as a Laser surgical instrument for use in general and plastic surgery and in dermatology (GEX). The components of the device include a mobile pole cart, controller console which plugs into a hospital- grade isolation transformer (attached with a bracket clamp to the pole cart), LED array mounted on an articulated arm (attached with a bracket clamp to the mobile pole cart), digital timer pre-selected for 8-minutes or 20-minutes, on/off switch, and a hospitalgrade power cable. The articulated arm allows the light fixture to be positioned in a wide variety of functional positions. The knuckles and joints on the arm allow the light fixture to be rotated, tilted, and raised/lowered independently. Treatment time is preset to 8 minutes for non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist, and thighs, (or 20 minutes for treatment of superficial, benign vascular and pigmented lesions, prior clearance K150336) via a validated internal timer delay relay. The light fixture is positioned 17cm (6.8″) from the patient's skin to deliver the standard dose output intensity of 105mW/cm²and standard energy dose of 126 J/cm². Photonica does not use any software.

Photonica Professional is indicated for use in dermatology for the treatment of superticial, benign vascular, and pigmented lesions.

The Photonica Professional ("Photonica") is a non-invasive red light system with a power output of 105mW/cm , consisting of 150 light emitting diodes (LEDs) that emit visible light at nominal wavelength of 635nm ± 2nm (visible red light spectrum) and a spectral bandwidth of 10nm, for treatment of superficial, benign vascular and pigmented lesions. The components include a mobile pole cart, controller console which plugs into a hospitalgrade isolation transformer (attached with a bracket clamp to the pole cart), LED array mounted on an articulated arm (attached with a bracket clamp to the mobile pole cart), 20 minute timer, on/off switch, and a hospital-grade power cable. The articulated arm allows the light fixture to be positioned in a wide variety of positions. The knuckles and joints on the arm allow the light fixture to be rotated, tilted, and raised/lowered independently. Treatment time is preset to 20 minutes via a validated internal timer delay relay. The light fixture is positioned 17cm (6.8″) from the patient's skin to deliver the standard dose output intensity of 105mW/cm and standard energy dose of 126 J/cm . Photonica does not use any software.