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The Nd:YAG 1064 Laser is intended for: • Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of Pseudofolliculitis Barbae (PFB). Permanent hair reduction is 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 lasers are indicated on all skin types, such as Fitzpatrick I-VI, including tanned skin. · Photocoagulation and hemostasis of benign pigmented and vascular lesions such as but not limited to port-wine stains, hemangioma, warts, telangiectasia, rosacea, venus lake, leg veins and spider veins. · Coagulation and hemostasis of soft tissue. · Treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sunspots cafe au lait macules, sebortheic keratosis, nevi, chloasma, verrucae, skin tags, keratosis), tattoos (significant reduction in the intensity of black and/or blue-black tattoos) and plaques. The laser is indicated for benign pigmented lessons to reduce lesion size, for patients with benign that would potentially benefit from aggressive treatment, and for patients with benign lesions that have not responded to other laser treatments. · Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. · Treatment of wrinkles. · Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes, Trichophyton rubrum and T. mentagrophytes, and for yeast Candida Albicans, etc.). The Alexandrite 755 laser is intended for: · Temporary hair reduction. · Stable long-term or permanent hair reduction through selective targeting of melanin in hair follicles. Permanent hair reduction is 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. On all skin types, such as Fitzpatrick I - V1, including tanned skin. · Treatment of benign pigmented lesions. · Treatment of wrinkles. · Photocoagulation of dermatological benign vascular lesions (such as port-wine stains, hemangiomas). The Alex+Nd:YAG (755 + 1064 lasers) is intended for: · Stable long-term or permanent hair reduction targeting of melanin in hair follicles. Permanent hair reduction is 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.

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The Nd:YAG 1064 Laser is intended for: - Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of Pseudofolliculitis barbae (PFB). Permanent hair reduction is 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 lasers are indicated on all skin types, such as Fitzpatrick I-VI, including tanned skin. - Photocoagulation and hemostasis of benign pigmented and vascular lesions such as, but not limited to, port-wine stains, hemangioma, warts, telangiectasia, rosacea, venus lake, leg veins and spider veins. - Coagulation and hemostasis of soft tissue. - Treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sunspots), café au lait macules, seborrheic keratosis, nevi, chloasma, verrucae, skin tags, keratosis, tattoos (significant reduction in the intensity of black and/or blue-black tattoos) and plaques. The laser is indicated for benign pigmented lesion size, for patients with benign lesions that would potentially benefit from aggressive treatment, and for patients with benign lesions that have not responded to other laser treatments. - Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. - Treatment of wrinkles. - Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes, Trichophyton rubrum and T. mentagrophytes, and for yeast Candida Albicans, etc.). The Alexandrite 755 laser is intended for: - Temporary hair reduction. - Stable long-term or permanent hair reduction through selective targeting of melanin in hair follicles. Permanent hair reduction is 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. On all skin types, such as Fitzpatrick I - VI, including tanned skin. - Treatment of benign pigmented lesions. - Treatment of wrinkles. - Photocoagulation of dermatological benign vascular lesions (such as port-wine stains, hemangiomas, telangiectasias).

The Splendor X (Alex, Alex , Nd:YAG, Alex + Nd: YAG), hereinafter referred to as "Splendor X", is a laser equipped with one or two solid-state laser sources. The 4 configurations differ for the internal crystals of the sources, that can be Alexandrite and/or Nd:YAG. The emitted laser radiation has a wavelength of 755nm, respectively, and 1064nm: - Alex configuration has only one source and one wavelength available (755 nm). - . Alex configuration has two sources of the same wavelength (755 nm), in order to increase the maximum power available. - Nd:YAG configuration has only one source and one wavelength available (1064 nm). - . In the Alex+Nd:YAG configuration has both the two wavelengths available (755 nm and 1064 nm). In this configuration the two wavelengths can act only individually, simultaneous operations are not allowed. This configuration works with three different modes: only with Alex source, only with Nd:YAG source or in the BlendX mode. With the BlendX mode, an initial pulse with Alexandrite source is followed automatically, without overlapping in time, by another pulse of the Nd:YAG source. This device is intended for medical use only.

The NuEra Tight RF Model OptiStream is intended: - to provide topical heating to treat selected medical conditions such as for temporary relief of pain or muscle spasms and to increase local circulation on body and face. - to provide, with a massage device, a temporary reduction in the appearance of cellulite.

NuEra Tight RF Family is a family of devices designed to develop localized heat to warm the subcutaneous tissue by means of radio frequency energy, delivered through electrodes in contact with the patient. Specifically, there are two devices in the family: - NuEra Tight RF radiofrequency generator with single RF electrode connector - - NuEra Tight RF Plus radiofrequency generator with single RF electrode connector. In addition, the NuEra Tight RF Plus has a larger size to accommodate an additional electronic part that has previously been cleared (K201239) and classified under procode NGX (Stimulator, Muscle, Powered, For Muscle Conditioning, 21 CFR § 890.5850); hence, this model provides the functions classified under both procodes PBX and NGX. The treatment performed by the NuEra Tight RF Family consists of increasing the temperature of the treated tissues up to maximum of 45°C. Therefore, depending on the treatment and intended use, different parts of the body can be treated. The models use RF monopolar and bipolar capacitive electrodes. Monopolar capacitive RF electrodes have different sizes and plug into an RF handpiece that provides connection to the RF generator. Handpieces of different shapes are available to facilitate use by the operator on different body parts. Capacitive electrodes work in combination with a return plate that must be in contact with the patient's body during the treatment in order to close the circuit with the RF generator. Return plates are available as single use, with specific connectors on the panel below the front tray of the main control unit. One bipolar capacitive electrode is provided fixed to a dedicated handpiece intended for the treatment of small body areas. Being bipolar, the electrode is not meant to work with a return plate. One massage handpiece is provided to be used to add a mechanical treatment to the heat emission. All the handpieces are used with a small amount (approximately 1 mm layer) of cream, that is Parker Redux cream K782055. The cream purpose is to provide a lubricious coating to allow the user to glide the electrode over the treated area and to ensure conduction with the return element on the bipolar electrode. A footswitch is provided as an optional user interface that allows to start and stop the medical treatment. It can be used as an alternative to the GUI start and stop button. The Pause Handpiece can be used to pause the treatment without using the GUI. The labeling changes proposed in this submission are to clarify that the use of the device to provide topical heating to increase local circulation is not limited to the body but can also include the face with the exception being within the orbital rim and on the neck.

The NuEra Tight RF and NuEra Tight RF Plus are intended: - to provide topical heating for the purpose of elevating tissue temperature for the treatment of conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. - to provide, with a massage device, a temporary reduction in the appearance of cellulite. - to provide, via heat-induced lipolysis at 1 and 2 MHz, abdominal circumference reduction with adjunctive improvement in the appearance of skin laxity.

NuEra Tight RF and NuEra Tight RF Plus are designed to develop localized heat to warm the subcutaneous tissue by means of radio frequency energy, delivered through electrodes in contact with the patient. Specifically, - NuEra Tight RF radiofrequency generator with single RF electrode connector. - - NuEra Tight RF Plus radiofrequency generator with single RF electrode connector. In addition, the NuEra Tight RF Plus has a larger size to accommodate an additional electronic part that has previously been cleared (K201239) and classified under procode NGX (Stimulator, Muscle, Powered, For Muscle Conditioning, 21 CFR § 890.5850); hence, this model provides the functions classified under both procodes PBX and NGX. The treatment performed by the NuEra Tight RF models consists of increasing the temperature of the treated tissues up to maximum of 45°C. Therefore, depending on the treatment and intended use, different parts of the body can be treated. The models use RF monopolar and bipolar capacitive electrodes. Monopolar capacitive RF electrodes have different sizes and plug into an RF handpiece that provides connection to the RF generator. Handpieces of different shapes are available to facilitate use by the operator on different body parts. Capacitive electrodes work in combination with a return plate that must be in contact with the patient's body during the treatment in order to close the circuit with the RF generator. Return plates are available as reusable or single use, with specific connectors on the panel below the front tray of the main control unit. One bipolar capacitive electrode is provided fixed to a dedicated handpiece intended for the treatment of small body areas. Being bipolar, the electrode is not meant to work with a return plate. One massage handpiece is provided to be used to add a mechanical treatment to the heat emission. All the handpieces are intended to be used with a small amount (approximately 1 mm layer) of an RF conductive cream (Parker Redux cream, cleared under K782055, or similar cream available in the US). The purpose of the cream is to provide aid to transfer the heat. A footswitch is provided as an optional user interface that allows to start and stop the medical treatment. It can be used as an alternative to the GUI start and stop button. The pause handpiece is an optional accessory can be used to pause the treatment without using the GUI.

The NuEra Tight RF Model APMD145.M70-US is intended for: - to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. - to provide, with a massage device, a temporary reduction in the appearance of cellulite.

NuEra Tight RF Family is a family of devices designed to develop localized heat to warm the subcutaneous tissue by means of radio frequency energy, delivered through electrodes in contact with the patient. Specifically, there are two devices in the family: - NuEra Tight RF radiofrequency generator with single RF electrode connector - - -NuEra Tight RF Plus - radiofrequency generator with single RF electrode connector. In addition, the NuEra Tight RF Plus has a larger size to accommodate an additional electronic part that has previously been cleared (K201239) and classified under procode NGX (Stimulator, Muscle, Powered, For Muscle Conditioning, 21 CFR § 890.5850); hence, this model provides the functions classified under both procodes PBX and NGX. The treatment performed by the NuEra Tight RF Family consists of increasing the temperature of the treated tissues up to maximum of 45°C. Therefore, depending on the treatment and intended use, different parts of the body can be treated. The models use RF monopolar and bipolar capacitive electrodes. Monopolar capacitive RF electrodes have different sizes and plug into an RF handpiece that provides connection to the RF generator. Handpieces of different shapes are available to facilitate use by the operator on different body parts. Capacitive electrodes work in combination with a return plate that must be in contact with the patient's body during the treatment in order to close the circuit with the RF generator. Return plates are available as reusable or single use, with specific connectors on the panel below the front tray of the main control unit. One bipolar capacitive electrode is provided fixed to a dedicated handpiece intended for the treatment of small body areas. Being bipolar, the electrode is not meant to work with a return plate. One massage handpiece is provided to be used to add a mechanical treatment to the heat emission. All the handpieces are used with a small amount (approximately 1 mm layer) of cream, that is Parker Redux cream K782055. The cream purpose is to provide a lubricious coating to allow the user to glide the electrode over the treated area and to ensure conduction with the return element on the bipolar electrode. A footswitch is provided as an optional user interface that allows to start and stop the medical treatment. It can be used as an alternative to the GUI start and stop button. The pause handpiece can be used to pause the treatment without using the GUI. A new accessory, proposed in this submission, is the Handsfree Accessory. The Handsfree will enable the same treatment without requiring the operator to manually move the handpiece and connected electrode over the entire treatment area. This is because the Handsfree electrodes (up to 8) can be connected together in a row with a belt, and also used with a double-sided adhesive tape, to better attach to the entire treatment area.

The NuEra Tight RF Family is intended for: - to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. - to provide, with a massage device, a temporary reduction in the appearance of cellulite.

NuEra Tight RF Family is a family of devices designed to: - develop localized heat to warm the subcutaneous tissue by means of radio frequency energy, delivered through electrodes in contact with the patient. Specifically, there are two devices in the family: - -NuEra Tight RF - radiofrequency generator with single RF electrode connector - -NuEra Tight RF Plus - radiofrequency generator with single RF electrode connector. The device has a different design, in particular for larger size, than the NuEra Tight RF, for the presence of an additional electronic part that is cleared under K201239. The purpose of the treatment based on the radiofrequency system (NuEra Tight) is to raise the temperature inside the tissues up to maximum of 45℃. Therefore, depending on the treatment and intended use, different parts of the body can be treated. The devices use RF electrodes of the capacitive (or monopolar) and resistive (or bipolar) types. Capacitive RF electrodes have different sizes and plug into an RF handpiece that provides connection to the RF generator (through the electrode connectors). Handpieces of different shapes are available to facilitate use by the operator on different body parts. The small area handpiece tip is provided sterile and disposable. The tip is Eto sterilized, the sterilization process was verified and validated using FDA-recognized standards UNI EN ISO 11138-1, UNI EN ISO 11138-2 and UNI EN ISO 11138-7. Also, the package integrity and shelf-life for this change have been evaluated through accelerated aging using American Society for Testing and Materials (ASTM) F1980. Capacitive electrodes work in combination with a return plate that must be in contact with the patient's body during the treatment in order to close the circuit with the RF generator. Return plates can be reusable or disposable, with specific connectors on the front tray. One resistive electrode is provided fixed to a dedicated handpiece intended for the treatment of small body areas. The resistive electrode, being bipolar, is not meant to work with the return plate. One massage handpiece is provided to be used to add a mechanical treatment to the heat emission. All the handpieces are used with a small amount (approximately 1 mm layer) of cream, that is Parker Redux cream K782055. The cream purpose is to provide aid to transfer the heat. A footswitch is provided as an optional user interface that allows to start and stop the medical treatment. It can be used as an alternative to the GUI start and stop button. The pause handpiece can be used to pause the treatment without using the GUI.

The NuEra Tight Family, EMS Model, is intended for: - improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen; - strengthening, toning and firming of buttocks, thighs and calves; - improvement of muscle tone and firmness, for strengthening muscles in arms.

NuEra Tight Family, EMS Model, is a family of devices designed to: - produce an electromagnetic field that induces electrical current in the muscles. By muscle stimulation, the system helps to strengthen, tone and firm the abdomen, buttocks, thighs and calves. The device belonging to the NuEra Tight Family, EMS Model, generates an intense magnetic field which is used to stimulate muscles trough two EMS handpieces, one small and one large, which can treat body parts of different sizes.

The NuEra Tight RF Family is intended for: - to provide topical heating for the purpose of elevaing tissue temperature for the treatment of selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. - to provide, with a massage device, a temporary reduction in the appearance of cellulite.

NuEra Tight RF Family is a family of devices designed to: - develop localized heat to warm the subcutaneous tissue by means of radio frequency energy, delivered through electrodes in contact with the patient. Specifically, there are two devices in the family: - -NuEra Tight RF - radiofrequency generator with single RF electrode connector - -NuEra Tight RF Plus -radiofrequency generator with single RF electrode connector. The device has a different design, in particular for larger size, than the NuEra Tight RF, for the presence of a disabled electronic part that is the object of a different 510(k) submission. The detachable components to be used with the part not available are not provided with the Nuera Tight RF Plus. The purpose of the treatment based on the radiofrequency system (NuEra Tight) is to raise the temperature inside the tissues up to maximum of 45°C. Therefore, depending on the treatment and intended use, different parts of the body can be treated.

The Nd: Yag 1064 Laser is intended for: - Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment hair reduction is 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 lasers are indicated on all skin types Fitzpatrick I-VI including tanned skin. - Photocoagulation and hemostasis of benign pigmented and vascular lesions such as but not limited to port wine stains, hemangioma, warts, telangiectasia, rosacea, venus lake, leg veins and spider veins. - Coagulation and hemostasis of soft tissue. - Treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, sebortheic keratosis, nevi, chloasma, verrucae, skin tags, keratosis, tattoos (significant reduction in the intensity of black and/or blue-black tattoos) and plaques. The laser is indicated for benign pigmented lesions to reduce lesion size, for patients with benign lesions that would potentially benefit from aggressive treatment, and for patients with benign lesions that have not responded to other laser treatments. - Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. - Treatment of wrinkles. The Nd:Yag 1064 Laser is intended for: - Temporary increase of clear nail in patients with onychomycosis (e.g., derniatophyton rubrum and T. mentagrophytes, and for yeast Candida Albicans, etc.) The Alexandrite 755 laser is intended for: - Temporary hair reduction. - Stable long-term or permanent hair reduction through selective targeting of melanin in hair follicles. Permanent hair reduction is 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. On all skin types (Fitzpatrick I - VI) including tanned skin. - Treatment of benign pigmented lesions. - Treatment of wrinkles. - Photocoagulation of dermatological benign vascular lesions (such as port-wine stains, hemangiomas, telangiectasias).

The FAMILY OF SQUARE EPIL LASER , is a laser equipped with one or two solid-state laser sources: As shown in the previous table, the 4 configurations of the Family differ for the internal crystals of the sources, that can be Alexandrite and/or Nd:YAG. The emitted laser radiation has a wavelength of 755nm, respectively, and 1064nm: -Alex configuration has only one source and one wavelength available (755 nm). -Alex configuration has two sources of the same wavelength (755 nm), in order to increase the maximum power available. -Nd:Yag configuration has only one source and one wavelength available (1064 nm). -In the Alex+Nd: Yag configuration has both the two wavelengths available (755 nm and 1064 nm) but can act only individually, simultaneous operations are not allowed. This device is intended for medical use only.

The Family of Radiofrequency System (Biorevital RF MED, ThermiSmooth 250) device is intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The Family of Radiofrequency System (Biorevital RF MED, ThermiSmooth 250) massage device is intended to provide a temporary reduction in the appearance of cellulite.

The Family of Radiofrequency System (Biorevital RF MED, ThermiSmooth 250) is a medical electrical equipment for the development of localized heat that can heat the subcutaneous tissue with radio frequency. Its particular emission frequency of 470 kHz ± 10%, the ability to regulate and control the increase of the desired temperature allows to operate with a maximum temperature of 45 ° C, and never exceed 47 °C (for safety). The electrodes dimensions included, allow to obtain a controlled heating.