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The CLEAR + BRILLIANT TOUCH® System is indicated for use in dermatological procedures requiring the coagulation of soft tissue and general skin resurfacing procedures.

The CLEAR + BRILLIANT TOUCH® Laser System is the second generation of the Clear+Brilliant line of products. Clear+Brilliant products use non-ablative laser designed for use in dermatological procedures intended to improve the appearance of a patient's skin. The system incorporates self-diagnostic algorithms to ensure its correct operation. The CLEAR + BRILLIANT TOUCH® Laser System is part of the family of Solta Medical products using the fractional photothermolysis principle to resurface the skin. CLEAR + BRILLIANT TOUCH® Laser System is comprised of four sub-systems: - 1. Console - 2. Handpieces: 1440nm and 1927nm (Perméa) handpieces - 3. Treatment Tip - 4. Credit Key The console and up to two handpieces are connected mechanically and electrically by an umbilical cable. The treatment tip is mechanically and magnetically secured to the handpiece. All components must be properly connected and fully functional for the system to be operable. The system will not permit laser energy output until the treatment tip is in contact with the patient's skin. The embedded processor and software control the precise delivery of the fractional laser treatment by directing the electrical and mechanical components that determine the position, spacing, and focus of the optical output. The processor and software also monitor the status of a treatment and the system and present this information to the operator on the touchscreen. The Credit Key is the replaceable accessory allowing access to treatment credits and is attachable to the console. It is removable and is disposed of after the credit balance reaches zero. The solid-state design of CLEAR + BRILLIANT TOUCH® Laser System limits maintenance and minimizes utility requirements.

The radiofrequency-energy only delivery components of the Thermage CPT® System and Accessories are indicated for use in: - Dermatologic and General Surgical procedures for electrocoagulation and hemostasis: - Non-invasive treatment of periorbital wrinkles and rhytids including upper and lower eyelids; - Non-invasive treatment of wrinkles and rhytids. The simultaneous application of radiofrequency energy and skin vibration by the Thermage CPT® System and Accessories in indicated for use in: - Dermatologic and General Surgical procedures for electrocoagulation and hemostasis; - Non-invasive treatment of periorbital wrinkles and rhytids; - Non-invasive treatment of wrinkles and rhytids; - Temporary improvement in the appearance of cellulite; - Relief of minor muscle aches and pains; - Relief of muscle spasms; - Temporary improvement of local circulation (i.e., blood circulation).

The Thermage CPT System delivers monopolar radiofrequency energy for selective coagulation of tissue while conductively cooling the epidermis. Cleared for commercial distribution under K090580, the Thermage CPT System delivers a maximum power of 500W of energy from the disposable tip to the patient. The Handpiece delivers output energy and cooling while also offering user-selectable vibration in the vertical dimension for mechanical manipulation of tissue. Vibration is active only during each treatment cycle while the 3cm² treatment tip is in contact with the skin. Vibration is not active when either the activation switch is released, when the treatment tip is not in contact with the skin, or when the 0.25cm2 eye tip is used. Single-use, disposable Treatment Tips are attached to the Handpiece that comes in contact with the patient during the treatment procedure. The Treatment Tip is classified as a direct skin contact device of limited duration (<24 hours). Tips are interchangeable to allow for treatment of a broad range of depths and surface areas. The Thermage CPT System includes the major components listed below: TG-2B Console, TH-3 Hand Piece, TH-4 Hand Piece, Thermage Treatment Tips (sizes range from 0.25cm² to 16.0cm²), Footswitch, Return Pad, Return Pad Cable, Skin Marking Grid Paper, Coupling Fluid, Cryogen.

1550 nm: The Fraxel 1550 nm laser is indicated for use in dermatological procedures requiring the coagulation of soft tissue, as well as for skin resurfacing procedures. It is also indicated for treatment of dyschromia and cutaneous lesions, such as, but not limited to lentigos (age spots), solar lentigos (sun spots), actinic keratosis, and melasma, and for treatment of periorbital wrinkles, acne scars and surgical scars. 1927 nm: The Fraxel 1927 nm laser is indicated for use in dermatological procedures requiring the coagulation of soft tissue, treatment of actinic keratosis, and treatment of pigmented lesions such as, but not limited to lentigos (age spots), solar lentigos (sun spots) and ephiledes (freckles).

The Fraxel DUAL 1550/1927 nm Laser System consists of a 1550 nm laser source and a 1927 nm laser source with fiber delivery and control by an embedded processor for use in dermatological procedures. The laser system uses scanning and focusing optics to deliver a controlled pattern of thermal energy to the epidermis and dermis. Device accessories include tip kits and pre-treatment solution.

Treatment of mild to moderate acne, including pustular acne, comedonal acne and mild to moderate inflammatory acne (acne vulgaris) in all skin types (Fitzpatrick I-VI).

The Isolaz® 2 System delivers non-coherent 400-1200 nm and 550-1200 nm intense pulsed light via a delivery handpiece utilizing photopneumatic technology. The system consists of a main console and a treatment handpiece. The desired power and delivery time are set by the operator. The modifications made to the device were to reduce and simplify device settings.

Dermatological procedures requiring the coagulation of soft tissue and general skin resurfacing procedures.

The Clear + Brilliant™ Laser System is a non-ablative laser system designed for use in non-invasive dermatological procedures. The Clear + Brilliant Laser System has a laser source in the hand piece which is controlled by an embedded processor. The console is electrically connected to the facility power source. Laser energy produced by the unit is delivered to the tissue through the removable (disposable) contact treatment tips which attach to the hand piece. The original Clear + Brilliant Laser System has a single hand piece containing a 1440 nm diode laser. A second hand piece with a 1927 nm diode laser has been added to the system as a line extension which provides an additional laser wavelength option at the same low power settings of the predicate Clear + Brilliant Laser System.

Dermatological procedures requiring the coagulation of soft tissue and general skin resurfacing procedures.

The CLEAR+BRILLIANT™ Laser System is a non-ablative laser system designed for use in non-invasive dermatological procedures. The CLEAR+BRILLIANT™ Laser System has a laser source in the hand piece which is controlled by an embedded processor. The console is electrically connected to the facility power source. Laser energy produced by the unit is delivered to the tissue through the removable (disposable) contact treatment tips which attach to the hand piece.

1550 nm. The Fraxel re:store 1550 nm laser is indicated for use in dermatological procedures requiring the coagulation of soft tissue, as well as for skin resurfacing procedures. It also indicated for treatment of dyschromia and cutaneous lesions, such as, but not limited to lentigos (age spots), solar lentigos (sun spots), actinic keratosis, and melasma, and for treatment of periorbital wrinkles, acne scars and surgical scars. 1925 nm: The Fraxel re:store 1925 nm laser is indicated for use in dermatological procedures requiring the coagulation of soft tissue.

Fraxel re:store (SR 1500) Laser System and Accessories

The radiofrequency-energy only delivery components of the Thermage ThermaCool NXT System and Accessories are indicated for use in: - Dermatologic and general surgical procedures for electrocoagulation and hemostasis; - Non-invasive treatment of periorbital wrinkles and rhytids including upper and lower eyelids; - Non-invasive treatment of wrinkles and rhytids. The simultaneous application of radiofrequency energy and skin vibration by the Thermage ThermaCool NXT System and Accessories is indicated for use in: - Dermatologic and general surgical procedures for electrocoagulation and hemostasis; - Non-invasive treatment of periorbital wrinkles and rhytids; - Non-invasive treatment of wrinkles and rhytids; - Temporary improvement in the appearance of cellulite; - Relief of minor muscle aches and pains; - Relief of muscle spasms: - Temporary improvement of local circulation (i.e., blood circulation).

The Thermage ThermaCool NXT System delivers capacitively coupled radiofrequency energy while cooling tissue by conduction. Components and accessories include the Multiplex (16.0) Handpiece, Standard Handpiece, Treatment Tips, Return Pad, Electronic Footswich (optional), Cryogen Canister and Coupling fluid. The front panel of the ThermaCool NXT System is equipped with a receptacle to connect the Return Pad to each Handpiece Assembly, comprising the return path for electric current. The modified Standard Handpiece offers user-selectable vibration to provide concurrent mechanical manipulation of tissue in a manner similar to the predicate devices listed.