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The DEPILASE YAG LASE PLUS Laser System is intended for the coagulation and haemostasis of vascular lesions, the removal and permanent reduction of unwanted hair in Fitzpatrick skin type I - VI and for the use in dermatological applications for the treatment of facial wrinkles.

The DEPILASE YAG LASE PLUS Laser System is based on Nd: YAG laser technology. Within the system, an optical cavity contains the Nd: YAG crystal. which is activated by means of the use of a flashlamp. After the cavity, a red diode aiming beam is reflected onto a coaxial beam path using a beamsplitter assembly. The combined therapeutic and aiming beams are guided down an optical fibre delivery system to a focusing handpiece. The laser is used in a non-contact mode.

The DEPILASE YAG LASE PLUS Laser System is designed with 5 major sub-systems:
a) A high voltage power supply which converts and rectifies the a.c. mains current to provide regulated power for the flashlamp simmer current and main triggering pulse.
b) A cooling system consisting of an internal water flow circuit together with water to air heat exchanger.
c) An Nd: YAG laser rod, capable of generating optical pulses at a frequency up to 3 Hz
d) An optical delivery system, interfacing the energy from the laser to the patient via an optical fibre and focusing handpiece.
e) The microprocessor based controller which regulates the functions of the laser and allows parameter selection by the user.

The provided document is a 510(k) summary for the DEPILASE YAG LASE PLUS Laser System. It focuses on demonstrating substantial equivalence to a predicate device and does not contain information about a study to prove adherence to specific performance acceptance criteria for the treatment of facial wrinkles.

Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, sample sizes, expert qualifications, or study methodologies because this information is not present in the document.

The document states:

• Intended Use: The DEPILASE YAG LASE PLUS Laser System is indicated for the use in dermatological applications for the treatment of facial wrinkles.
• Substantial Equivalence: Depilase believes its device is substantially equivalent to the Laserscope Lyra (K020021) Nd: YAG laser, previously cleared for the use in dermatological applications for the treatment of facial wrinkles.

This 510(k) summary relies on demonstrating that the new device has similar technological characteristics, intended use, and comparable risks and benefits to a previously cleared device. It does not describe a new clinical study with specific acceptance criteria to evaluate the effectiveness of the DEPILASE YAG LASE PLUS Laser System for facial wrinkle treatment.

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