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The GME TwinScan 808/755 Laser System is indicated for hair removal and permanent hair reduction defined as the stable, long-term reduction in hair counts at 6, 9, or 12 months following a treatment regime.

The GME TwinScan 808/755 Laser System is intended to be used on all skin types (Fitzpatrick I-VI).

The TwinScan 808/755 Laser System is a diode laser designed to be used in Dermatological practice for stable, long term hair reduction.

The TwinScan 808/755 Laser System consists of a base unit (touch screen, mains switch, key switch, Emergency Stop button) that controls an applicator unit. The applicator unit contains the diode laser and scanner. The device may be configured with 808 nm or 755 nm Applicators, in two treatment area sizes, at the factory. The TwinScan 808/755 Laser System includes the following accessories: Power cord, foot switch, laser protective goggles, applicator holder, and coolant refill kit. A cooled sapphire is the only patient contacting part of the system. There are no single use parts in the TwinScan 808/755 Laser System.

Principle of Operation: The laser light is converted to heat when it strikes a chromophore (pigment). The heat denatures the protein of the chromophore (in this case, hair follicle). Specifically, the hair follicle contains pigment and reacts to laser light by heating. Heating denatures proteins in the hair follicle, retarding hair growth.

I am sorry, but the provided text does not contain information on the acceptance criteria and a study that proves the device meets those criteria. The document is an FDA 510(k) premarket notification for the "TwinScan 808/755 Laser System", primarily focusing on establishing substantial equivalence to predicate devices. It lists device specifications and indications for use, but does not detail acceptance criteria or specific clinical study results for device performance against those criteria. It only mentions that performance data was submitted, specifically "Testing reports for IEC 60825-1 and IEC 60601-2-22" and "IEC 60601-1 and IEC 60601-1-2", which refer to international safety standards for laser products and medical electrical equipment. These are not clinical studies demonstrating the effectiveness of the hair removal or permanent hair reduction claims.

Therefore, I cannot provide the requested table or detailed information regarding sample sizes, ground truth, expert qualifications, or MRMC studies.

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