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1550 nm: The Fraxel 1550 nm laser is indicated for use in dermatological procedures requiring the coagulation of soft tissue, as well as for skin resurfacing procedures. It is also indicated for treatment of dyschromia and cutaneous lesions, such as, but not limited to lentigos (age spots), solar lentigos (sunspots), actinic keratosis, and melasma, and for treatment of periorbital wrinkles, acne scars and surgical scars.

1927 nm: The Fraxel 1927 nm laser is indicated for use in dermatological procedures requiring the coagulation of soft tissue, treatment of actinic keratosis, and treatment of pigmented lesions such as, but not limited to lentigos (age spots), solar lentigos (sunspots) and ephelides (freckles).

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The document provided is an FDA 510(k) clearance letter for a medical device called the "Fraxel® FTX Laser System." It does not contain any information about acceptance criteria, device performance studies, sample sizes, data provenance, expert qualifications, ground truth establishment, or any details typically associated with the evaluation of AI/ML-based medical devices or comparative effectiveness studies.

This document merely confirms that the FDA has reviewed the premarket notification for the Fraxel® FTX Laser System and determined it is substantially equivalent to legally marketed predicate devices for its stated indications for use (dermatological procedures involving soft tissue coagulation, skin resurfacing, treatment of various skin lesions, wrinkles, and scars).

Therefore, I cannot fulfill the request as the necessary information is not present in the provided text.

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