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The BIOSY AG 50 Med laser is indicated for treatment of benign vascular lesions and hair reduction. The equipment should only be used under medical supervision.

The BIOSYAG 50 Med laser is a pulse Nd: YAG laser utilizing the Nd:YAG crystal as the lasing medium. It is a pulsed laser with wavelength of 1064 nm. Within the system an optical cavity contains the Nd: YAG crystal which is activated by means of the use of flash lamps. After the cavity a red diode aiming beam is reflected onto a coaxial beam path using a beamsplitter assembly. The combined therapeutic and aiming beam are guided down an optical fiber delivery system to a focusing handpiece. The laser is used in non-contact mode. The BIOS YAG 50 Med laser is composed by 5 major subsystems: a) A high voltage power supply which converts and rectifies the a.c. main current to provide regulate power for the flashlamp simmer current and main triggering pulse. b) A cooling system consisting of an internal water flow circuit with water-to-air hath exchanger. c) An optical delivery system, interfacing the energy from the laser to patient via an optical fiber and focusing handpiece. d} A microprocessor based controller which regulates the functions of the laser and allows parameter selection by the user.

The provided document is a 510(k) Premarket Notification for the BIOSYAG 50 Med, a medical laser system. It explicitly states "Non-Clinical Performance Data: None" and "Clinical Performance Data: None".

Therefore, based on the provided text, there is no information available about acceptance criteria or a study proving the device meets those criteria.

The document focuses on establishing substantial equivalence to a predicate device (Cynosure Smartepil) based on product specifications, functionality, indication for use, and treatment parameters, rather than presenting performance data from a specific study.

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