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The CO2-2B Galaxy CO2 Laser System is intended for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery, general surgery. Dermatology, Plastic Surgery and General Surgery procedures: Laser skin resurfacing. Treatment of furrows and wrinkles. Removal of skin tags, actinic keratosis, acne scars, keloids, tattoos, telangiectasia, squamous and basal cell carcinoma, warts and uneven pigmentation. Treatment of cysts, abscesses, hemorrhoids and other soft tissue applications. Blepharoplasty. Site preparation for hair transplants. The fractional scanner is for treatment of wrinkles and skin resurfacing.

Galaxy CO2 Laser System consists of Mainframe, Optical Delivery System, Protective Glasses and Footswitch. Mainframe consists of CO2 laser generator, laser power supply, control device, safety protection system and cooling system. Optical delivery system consists of articulated arm, aiming beam, normal handpiece and fractional scanner handpiece. Galaxy CO2 Laser System produces a beam of coherent infrared light --- 10.6µm laser which is near the peak of tissue water absorption. When the water in the tissue absorbs the laser energy, it heats up. The heating causes instantaneous vaporization of the target issue. Equipped with the scanner, the system delivers a high-speed laser scan with micro spots for optional control of treatment area and depth.

- · Tattoo Removal - · Treatment of Vascular Lesions - · Treatment of Pigmented Lesions, - · Incision, Excision, Ablation, Vaporization of Soft Tissue for General Dermatology 1064nm: Tattoo Removal: Dark ink: blue and black Treatment of Pigmented Lesions: Nevus of ota 532nm: Tattoo Removal: Light ink: red, Light ink: sky blue and green Treatment of Vascular Lesions: Port wine birthmarks, Telangiectasias, Spider angioma, Cherry angioma, Spider nevi Treatment of Pigmented Lesions: Café-au-lait birthmarks, Solar lentiginos, Senile lentiginos, Becker's nevi, Freckles, Nevus spilus

The Nd: YAG Laser System is based on the Q-Switched Nd:YAG (1064 nm) and frequency doubled KTP Nd:YAG (532 nm) laser technology. There is one optical cavity containing the Nd:YAG crystal. The frequency doubled KTP Nd:YAG wavelength is achieved by directing the Nd:YAG laser beam through a frequency doubling non-linear crystal. The Nd:YAG laser is activated by means of the use of flashlamp. A red diode aiming beam is reflected onto a coaxial beam path using a beamsplitter assembly. The combined therapeutic and aiming beams are guided by articulated arm to a focusing handpiece. Both laser wavelengths share a common power supply, control system, and cooling system. The internal microprocessor can be directed to select either the Nd:YAG or the KTP Nd:YAG laser wavelength. The physician is able to select the desired wavelength and the related output energy ,spot size ,fluence via control panel.

The new device Speed 808 Diode Laser System is intended for use in dermatologic and general surgical procedures. The Speed 808 Diode Laser System is indicated for hair removal, permanent hair reduction. The 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 regimen. The Speed 808 Diode Laser System is intended for use on all skin types (Fitzpatrick skin types I - VI), including tanned skin.

Speed 808 Diode Laser System are new devices for 510(k) submission and share the similar indication for use and safety compliance, similar design features and functional features with the predicate devices. The complete system consists of a console, a handpiece connected to the system by an umbilical cord and a footswitch. There are two important components in the handpiece: a diode laser inserted in the handpiece and a sapphire-made aperture with an area of 10mmX10mm through which laser energy is emitted. A cooling system effectively works on the sapphire-made aperture and can ensure enough and continuous protection of skin. The handpiece is pressed against the patient's skin and a pulse of laser is delivered. To initiate energy output, the system requires the activation of the handpiece trigger or the footswitch. Laser specifications and other system features are controlled from the Operating Buttons and LCD screen on top of the console, which provide interface with the system computer.