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The NuFACE FIX+ Device is intended for facial stimulation and is indicated for over-the-counter cosmetic use.

FIX+ is a portable hand-held microcurrent stimulator for facial skin stimulation indicated for over-the-counter cosmetic use. Main components: Main unit, USB power cable, and NuFACE Line Smoothing FIX Serum conductivity gel. Housing of the device made from Acrylonitrile Butadiene Styrene, with chrome-plated spherical probes. Inclusion of three microcurrent output frequency levels. Integrated rechargeable lithium-ion battery.

The Trinity Plus Wrinkle Reducer is an over-the-counter hand-held for reduction of full-face fine lines and wrinkles, and increase in local circulation within the perioral region.

The Trinity Plus Wrinkle Reducer (hereinafter referred to as "TWR Plus") comprises the TWR Plus main body, a TWR Plus light attachment head, a charging cradle, and a wall-mount power adaptor. The device and all its associated components are reusable and provided non-sterile. The TWR Plus is a hand-held phototherapy device that emits Red and Infrared (IR) light energy in the 605, 630, 645, 660 and 855 nanometer wavelengths via a light attachment head. The light attachment head comprises (34) Light Emitting Diodes (LED's) which are the source of the light energy. The Red and IR light energy is used in the treatment of fine lines and wrinkles around eyes, mouth, and forehead and promotes local blood circulation. The subject device includes three indicator LED's, one internal speaker and one vibration motor. These features provide visual, audible, and haptic feedback to the user during normal operation. The light attachment head includes a proximity sensor to detect when device is pressed onto the skin. The subject device is turned on and turned off via a dedicated ON/OFF button. Once the subject device is ON, the user follows the provided Instructions for Use to start the treatment. The ON/OFF button also serves as a multi-function User Interface (UI) button by allowing the User to control other functions while the subject device is in Standby, Treating, Charging or Sleep modes. A long press of approximately one second on the ON/OFF button can stop treatment at any time. Upon power up, the three indicator lights turn on and an ascending audible beep is emitted notifying the user that the device is ON. Once the device is ON, the light therapy LEDs are set to a visible, but significantly dimmed non-treatment state. As the device is placed in direct contact with the skin, the proximity sensor will turn the light therapy LEDs on to start the treatment. While in treatment, if the device is moved away from the skin, the device emits three beeps, and the LEDs revert to the significantly dimmed non-treatment state. The device also emits two beeps to inform the user when a treatment interval is complete and that it is time to treat another section of skin. The device automatically Shuts OFF after 24 minutes of use to indicate the treatment is complete. The device is powered by one internal rechargeable, non-removable battery which is charged via a provided wireless charging cradle. The charging cradle is powered by a pre-approved wall-mount power supply. The light energy output power is zero watts while the device is in the charging cradle or when turned off. All charging circuitry is contained within the handheld unit itself. The housings of TWR Plus main body, the light attachment head and the charging cradle are made from injection molded thermoplastic resins. The light attachment head, which is intended to come in contact with the skin, is made from a biocompatible polymer material. The TWR Plus, including the light attachment head, measures 5.4" H x 2.6" W x 1.7" D and weighs 7.8 oz. The charging cradle measures 2.3" H x 3.0" W x 2.7" D and weighs 7.30 oz. The TWR Plus uses Bluetooth Low Energy (BLE) wireless technology to pair to and connect with compatible devices capable of running the NuFACE® App. The NuFACE® App allows the user to select and run pre-programmed treatment profiles stored in the device. Device component list: - 1 x TWR Plus Main Body - 1 x TWR Plus Light Attachment Head - 1 x Wireless Charging Cradle - 1 x Pre-approved wall-mount power adaptor

The Trinity ELE Plus and Trinity ELE Plus Pro devices are intended for facial stimulation and are indicated for over-the counter cosmetic use.

The Trinity ELE Plus comprises the Trinity ELE Plus device main body, a Trinity ELE Plus microcurrent attachment head, a charging cradle, and a wall-mount power adaptor. A tube of NuFACE® Gel Primer is provided with the subject device as an accessory. The subject device and all its associated components and accessories are reusable and provided non-sterile. The Trinity ELE Plus is a hand-held device that produces low levels of microcurrent which is discharged through two dual chrome-plated precise wands for aesthetic purposes. The device provides audible feedback to inform the user to relocate the device to treat a new location on the skin. The device also includes "hum" features to guide the user during the treatment cycle. The subject device is powered by one internal rechargeable, non-removable battery which is charged via a provided wireless charging cradle. The charging cradle connects to a provided wall-mount power adaptor. Microcurrent output is cut-off while the device is sitting on the charging cradle either charging the battery or when the battery is fully charged. The enclosures of the subject device main body, the attachment head and the charging cradle are made from injection molded ABS thermoplastic material. The same ABS material is used in other FDA-cleared devices. The dual chrome-plated precise wands on the attachment head use chromium. The same chromium material is used in the predicate device dual chrome-plated precise wands. The subject device, including the attachment head, measures 6.1" H x 2.4" W x 1.2" D. The charging cradle measures 2.3" H x 3.0" W x 2.7" D. The device includes an 'ON/OFF' multi-function button to turn the device on and off, start and stop treatment, increase or decrease the microcurrent output level and pair with a smart device. The device also includes a "BOOST" button that temporarily increases the microcurrent output level. The device includes indicator LED's to provide information to the user on the status of the device and the progress of the treatment. The subject device is the capable of pairing with compatible smart devices using Bluetooth Low Energy (BLE) wireless communications technology. This technology allows the subject device to communicate with other devices running the NūFACE® App which allows the user to select and run pre-programmed treatment profiles. The Trinity ELE Plus provides microcurrent output at selected frequencies from 0.3 to 50 Hz. The Trinity ELE Plus is available in two models, a Standard model and a 'Pro'' model. The Trinity ELE Plus Standard model has a maximum output current without Boost of 170 uA, and the Trinity ELE Plus Pro model has a maximum output current without Boost of 200 uA. All other aspects of the Trinity ELE Plus except those related to maximum output current, are the same between the Standard model and Pro models.

The NuFACE® Trinity Plus Device is intended for facial and neck stimulation and is indicated for over-the-counter cosmetic use.

The NuFACE® Trinity Plus comprises the Trinity Plus device main body, a Trinity Plus microcurrent attachment head, a charging cradle and a wall-mount power adaptor. A tube of NuFACE® Gel Primer is provided with the device as an accessory. The device and all associated components are reusable and provided non-sterile. The NuFACE® Trinity Plus is a hand-held device that produces low levels of microcurrent which is discharged through two dual-plated chrome spheres for aesthetic purposes. The device provides audible feedback to inform the user to relocate the device to treat a new location on the skin. The device also includes "hum" features to guide the user during the treatment cycle. The device is powered by one internal rechargeable, non-removable battery which is charged via a provided wireless charging cradle. The charging cradle connects to a provided wall-mount power adaptor. Microcurrent output is cut-off while the device is sitting on the charging cradle either charging the battery or when the battery is fully charged. The enclosures of the device main body, the attachment head and the charging cradle are made from injection molded ABS thermoplastic material. The dual spheres on the attachment head use chromium. The device includes an 'ON/OFF' multifunction button to turn the device on and off, start and stop treatment, increase or decrease the microcurrent output level and pair with a smart device. The device also includes a "BOOST" button that temporarily increases the microcurrent output level. The device includes indicator LED's to provide information to the user on the status of the device and the progress of the treatment. The device is the capable of pairing with compatible smart devices using Bluetooth Low Energy (BLE) wireless communications technology. This technology allows the device to communicate with other devices running the NuFACE® App which allows the user to select and run pre-programmed treatment profiles. The NuFACE® Trinity Plus provides microcurrent output at selected frequencies from 0.3 to 50 Hz.

The NuFACE Mini Device is intended for facial and neck stimulation and is indicated for over-the-counter use.

The NuFACE® Mini Device is an over- the- counter facial and neck toning device. The chrome plated dual spheres of the NuFACE® Mini are designed to gently glide over the skin to deliver low-level electrical impulses to strategic locations on the face and neck. The NuFACE® Mini electrodes are designed for optimal contact with the face. The NuFACE® Mini microcurrent continually alternates between the positive electrodes and allows the user to adjust settings. The NuFACE® Mini Device measures approximately 2.5" W x 4.2" D. Its outer case is injection mold thermoplastic resin. The device comes with an external Power Supply to recharge the lithium ion battery of the device when not in use. The external Power Supply is a pre- approved wall adapter. All charging circuitry is contained within the device itself.

The NuFACE FIX™ Device is intended for facial stimulation and is indicated for over-the-counter cosmetic use.

NuFACE FIX Skin Toning Device is intended for facial stimulation and is indicated for over-the-counter cosmetic use. Two (2) spherical electrodes, fixed on the NuFACE FIX device main face, deliver low level electrical impulses (aka. microcurrent) to targeted locations on the face.

The NuFACE Trinity is intended for facial and neck stimulation and is indicated for over-the-counter cosmetic use.

The NuFACE Trinity Device(proposed) is intended for facial and neck skin stimulation and is indicated for over-the-counter cosmetic use. It is identical to that of its NuFACE Plus (predicate) and its technological characteristics remain unchanged. It produces microcurrent discharged through the two spherical probes.

NuBODY Skin Toning Device is intended for body skin stimulation and is indicated for over-the-counter cosmetic use.

NuBODY Skin Toning Device is intended for body skin stimulation and is indicated for over-the-counter cosmetic use. Four (4) spherical electrodes, fixed on the NuBODY device main body, deliver low level electrical impulses (microcurrent) to targeted locations on the body.

The NuFACE Gel Primer is intended to be used with NuFACE microcurrent devices to improve skin conductivity.

The NuFACE Gel Primer is a clear, viscous and chloride-free formulation. The gel is to be applied to the area under an electrode to reduce the impedance of the contact interface between the electrode surface and the skin.

The NuFACE® Mini Device is intended for facial stimulation and is indicated for overthe-counter cosmetic use. (21 CFR 801 Subpart C).

The NuFACE® Mini Device is a non-invasive at home, over-the-counter facial toning device. The dual spheres of the NuFACE® Mini Device are designed for optimal contact with the face and are identical in size to the predicate device. The NuFACE® Mini Device is extremely responsive as it delivers soft wave micro-current in the millionths of an ampere and has the ability to increase facial contour and firm the skin and muscles. The NuFACE® Mini device measures 2.5" W x 4.2" L x 1.2" D. Its outer case is injection molded of thermoplastic resin. The device comes with an external Power Supply to charge the internal batteries of the device when not in use. The external Power Supply provides DC power from a pre-approved wall adapter. All charging circuitry is contained within the device itself. The microcurrent output is disabled when the device is connected to the external Power Supply. An ascending sequence of beeps informs the customer the NuFACE® Mini is ready for use. When the user turns the device OFF, a descending tone is emitted. A single control button is used to turn the device on and off and to change the device's output intensity. A long press of the control button toggles the device between on and off. To promote proper use, a single audio beep informs the user to relocate the device to treat a new location on the skin. The user can also adjust the output intensity by briefly pressing the control button to step between multiple micro-current output level selections. When the device is set to the maximum output and the control button is pressed, the device sequences to the minimum output.