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The Silk'n Toothwave is a powered radiofrequency toothbrush intended to promote good oral hygiene, including reduction of plaque, and the prevention and treatment of gingivitis. The Silk'n Toothwave is intended for over-the-counter use.

The Silk'n Toothwave device (a.k.a Silk'n H7001 Powered Toothbrush) is a handheld, rechargeable, powered, radiofrequency toothbrush, an over-thecounter device, intended to promote good oral hygiene, including reduction of plaque and the prevention and treatment of gingivitis. The Silk'n Toothwave Device is comprised of the handheld, brush head and recharging units. The device utilizes radio frequency (RF) energy and vibration. The Silk'n Toothwave is comprised of the handle, the brush head, and recharging unit. The brush head is designed with radiofrequency electrodes and bristles. The handheld unit contains the software, programming, and hardware necessary for the device to function. The device is operated by a push button for activation of the radiofrequency and vibration. The Silk'n Toothwave device is operated by a single mode push-button located on the handle/hand piece user interface board and a set of light indicators informing the lay user of the device operation. The Silk'n Toothwave device is designed as a rechargeable handheld electrical toothbrush comprised of the charging base unit and a rechargeable power handheld unit. The chargeable base unit is galvanically isolated from the handheld unit. The Silk'n ToothWave Device is electrically safe in accordance with medical device electrical safety standards (IEC 60601-1, IEC 60601-2-2 and IEC 60601-1-11). The Silk'n ToothWave Device utilizes vibration and low power RF energy technologies. The action of the brush head has a vibration frequency up to 400Hz. The RF generator generates conductive RF energy at 3 MHz, with a maximal output power of 3W. The handle or hand piece brush head is designed as a medium oval brush head and features an arrangement of bristles surrounding two low profile hidden RF electrodes and a silicon barrier located in-between the two electrodes. The handle or hand piece is equipped with an ON/OFF switch and indicator panel that indicates the device status (RF activation, vibration level, charging, or error).

ToothWave™ is indicated as follows: ToothWave™ is a powered radiofrequency toothbrush intended to promote good oral hygiene, including reduction of plaque and the prevention and treatment of gingivitis. ToothWave™ is intended for over-the-counter use.

The ToothWave™ is a handheld rechargeable electric toothbrush intended to promote oral hygiene, including reduction in plaque and prevention and treatment of gingivitis. The device is for over-the-counter (OTC) use. The device is comprised of the handle, the brush head, and recharging unit. The device utilizes radiofrequency (RF) energy and tactile vibration. The device is operated by a single-mode push button located on the handle/user interface board and includes a set of light indicators informing the user of the device operation (RF activation, vibration level, charging, or error).

The Silk'n Model H5003 is indicated for the improvement of muscle tone and firmness, for strengthening muscles in arms, abdomen, thighs and buttocks areas. Contraindicated use on injured or otherwise impaired muscles. Not intended for use in any therapy or for the treatment of any medical conditions or diseases.

The Silk'n MODEL H5003 device is an over-the-counter home use EMS device intended for the improvement of muscle tone and firmness, for strengthening muscles in arms, abdomen, thighs, and buttocks areas. The Silk'n Model H5003 system is comprised of a treatment unit - "applicator", a belt for placing and holding the applicator and a cradle unit for charging of the applicator's battery. The device generates an electrical signal. which is required for muscle stimulation and is transferred to the muscles via the device electrodes. The Silk'n MODEL H5003 device is easily operated by a single mode push-button, two operational buttons for selection of EMS level, and a set of light indicators informing the lay-user on the device current operation mode (i.e., EMS level treatment, standby or error), all are located on the applicator user interface board. The Silk'n MODEL H5003 device is equipped with a safety proximity sensor, which initiates the signal only upon full contact between the electrodes and the skin, and disconnects the power in case of no contact during the device operation.

The Silk'n Infinity is an over the counter device intended for the removal of unwanted hair. The Infinity device is also intended for permanent reduction in hair regrowth, 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 regime. The Silk'n Infinity electric output is indicated for facial stimulation for over-the-counter aesthetic use.

The Silk'n Infinity device is designed as a hand held, home use device, which utilizes Intense Pulsed Light (IPL) for hair removal and galvanic microcurrents for skin stimulation. The device comprises a power adaptor and device applicator. The applicator consists of a single lamp producing the light energy that is emitted via the flash window, and a chrome-coting stripe (touch electrode) located around the flash window, through which the micro-current pulses are discharged. The applicator spot size is 2.7cm2 The user interface located on the applicator contains ON/OFF button, pulsed trigger button and six green LED indicators which provide information on the energy level, system status & errors. The Silk'n Infinity device contains a skin sensor, providing the user with an additional safety measure to detect appropriate skin tones and a proximity sensor that identifies full contact with the skin before pulse activation. The light output power range is from 3 to 5 J/cm 2, the optical filter cut off wavelength is 475-1200nm.

The Silk'n HST is an over-the-counter home use device intended for non-invasive treatment of mild to moderate periorbital wrinkles for adult women who have Fitzpatrick skin types I-IV.

The Silk'n HST device is designed as a hand held device, which utilizes both RF and low power light energies. The device includes RF generator, LEDs at wavelengths of 630±20nm and 850±20nm (red and IR wavelengths, respectively) and a temperature stabilizer. The Silk'n HST device consists of an applicator and an adaptor. The applicator is a handheld unit used for treatment. The treatment surface is located at the applicator tip and comes in direct contact with the skin. The applicator is equipped with an ON/OFF switch that also selects the energy level as manifested using indicators panel. The adaptor connects the applicator to the electrical outlet using its plug and the applicator socket.

HeatLux Pro II is an over the counter hand held device intended to emit energy in the visible, near IR, and RF spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscular and joint pain and stiffness, minor arthritis pain or muscle spasm, the temporary increase in local blood circulation, and temporary relaxation of muscles.

The HeatLux Pro II Device is an over the counter, hand held device, utilizing low power light spectrum, array of 24 LEDs, at wavelength of 630±10nm and 850±50nm, RF output power (1MHz. maximal output power 24W) and electrical heating. The HeatLux Pro II Device consists of an applicator and an adaptor. The applicator is a hand held unit used for treatment, as the treatment surface at the applicator tip comes in direct contact with the skin. The device applicator comprises temperature stabilizer, which constantly maintains the applicator temperature to 41ºc.

HeatLux Pro I is over the counter hand held device intended to emit energy in the visible and near IR spectrum to provide topical heating for the purpose of elevating tissue temperary relief of minor muscular and joint pan and stiffness, minor arthritis pam or muscle spasm, the temporary increase in local and blood carculation, and temporary relaxation of muscles.

The HeatLux Pro I device is a hand held device, using low power light spectrum, array of 24 LEDs, at wavelength of 630±10nm, combined with four metal heating plates (temperature stabilized to 41%). The HeatLux Pro I device consists of an applicator and an AC/DC power adaptor. The applicator is a hand held unit used for treatment, as the treatment surface at the applicator tip comes in direct contact with the skin.

The Glide™ device is an over the counter device intended for the removal of unwanted hair. The Glide™ device is also intended for permanent reduction in hair regrowth, 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 regime.

The Glide device is a pulsed light hair removal device. Light-based hair removal is based on the theory of selective photothermolysis in which optical energy is used to disable hair growth. The Glide device is composed of a hand held applicator. The device contains 6 LEDs indicating 5 different energy levels and other device functions. The spot size in the Glide device is 2.7cm2. The device contains a lamp, a temperature sensor, a skin proximity sensor and a skin color sensor to detect appropriate skin tones. The skin sensor scans darker skin tones and will not pulse if the skin tone is not suitable for treatment.

The Glide™ device is an over the counter device intended for the removal of unwanted hair. The Glide™ device is also intended for permanent reduction in hair regrowth, 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 regime.

The Glide device is a pulsed light hair removal device. Light-based hair removal is based on the theory of selective photothermolysis in which optical energy is used to disable hair growth. The Glide device is composed of a hand held applicator. The device contains 6 LEDs indicated 5 different energy levels and other device functions. The spot size in the Glide device is 2.7cm . The device contains a lamp, a temperature sensor, a skin proximity sensor and a skin color sensor to detect appropriate skin tones. The skin sensor scans darker skin tones and will not pulse if the skin tone is not suitable for treatment.

The Silkn Blue is indicated as an over the counter phototherapy device for the treatment of mild to moderate acne.

Silkn Blue is a hand held device battery operated that uses low power light spectrum, LED, at wavelength of 415 ±15 nm, combine with tip temperature stabilizer at 41ºC. The emitting optical power is in a uniform distribution with no hot spots.