CLARITY II Laser System

The CLARITY II 755 nm Laser System is indicated for temporary hair reduction and stable long-term or permanent 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. The 755 nm laser is also indicated for treatment of benign pigmented lesions, vascular lesions and wrinkles.

The CLARITY II 1064 nm Laser System is indicated for stable long term or permanent hair reduction and for treatment of PFB (Pseudofolliculitis Barbae) on all skin types, Fitzpatrick I – VI, including tanned skin. 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 1064 nm laser is also indicated for coagulation and hemostasis of soft tissue, for hemostasis of vascular lesions such as but not limited to port wine stains, hemangiomna, warts, telangiectasia, rosacea, venus lake, leg veins and spider veins. The 1064 nm laser system is also indicated for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), café au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, (significant reduction in the intensity of black and/or blue-black tattoos) and plaques. The 1064 nm Laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles.

The CLARITY II 755 nm Laser System is indicated for temporary hair reduction and stable long-term or permanent 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 1-VI) including tanned skin. The 755 nm laser is also indicated for treatment of benign pigmented lesions, vascular lesions and wrinkles. The CLARITY II 1064 nm Laser System is indicated for stable long term or permanent hair reduction and for treatment of PFB (Pseudofolliculitis Barbae) on all skin types, Fitzpatrick I – VI, including tanned skin. 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 1064 nm laser is also indicated for coagulation and hemostasis of soft tissue, for hemostasis of vascular lesions such as but not limited to port wine stains, hemangiomna, warts, telangiectasia, rosacea, venus lake, leg veins and spider veins. The 1064 nm laser system is also indicated for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), café au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, (significant reduction in the intensity of black and/or blue-black tattoos) and plaques. The 1064 nm Laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles.

The CLARITY II Laser System contains two separate resonators, an Alexandrite resonator and an Nd:YAG (Neodymium-doped Yttrium Aluminum Garnet) resonator which generates pulsed laser energy at the nominal wavelength 755 nm and 1064 nm, respectively. The outputs of each laser generator and the aiming beam are optically combined on the laser rail so that their beam paths are identical as they exit the laser system. This allows the use of a single delivery system for either the 755 nm or 1064 nm wavelength. It is a medical device, designed for specific clinical applications, emitting laser energy via a handpiece and controlled by the user with a handpiece finger switch or optional footswitch. The CLARITY II Laser System consists of a system main body with an LCD touch screen, optical fiber with an AC or ICD handpiece. The control panel is equipped with an LCD touch screen so that users may easily adjust parameters for optimal settings. The CLARITY II Laser System is composed of three main components, including the system main body, optical fiber (with optional AC handpiece or ICD handpiece), and the footswitch. The system main body is composed of the system control module, power supply, laser module, control panel (LCD touch screen), emergency stop button, and key switch. Laser radiation will be emitted from the handpiece through the optical fiber when the footswitch or finger switch is pressed. Safety goggles are provided with the system (optical density of 7 or higher at 1064 nm and 755 nm) for ancillary personnel. The casters and handle on the main body allows for transportation of the laser system within the treatment room. The laser console measures 563.6 mm (W) x 952.3 mm (L) x 998.5 mm (H). The laser delivery system begins at the laser aperture, which is the fiber socket, at the upper front of the device. At this point, the invisible and infrared laser beam (755 nm or 1064 nm) and the visible 515-535 nm aiming beam are fed into and pass through the optical fiber and exit at the handpiece aperture. Cartridges are available for the AC handpiece and ICD handpiece. The system is fitted with a window to protect the lens inside the cartridges from foreign material. The cartridge irradiation diameters available within the system are 2, 3, 5, 8, 10, 12, 15, 16, 18, 20, 22, 24mm. Users can use a cartridge fitted with an intelligent tracking tip (roller), O-type tip, C-type tip, or I-type tip. The AC handpiece can be used with the CryoMini air cooling system that