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The Sciton, Inc. Image Hair Removal Laser is intended for use in surgical and aesthetic applications requiring selective photothermolysis of target chromophores in soft tissue in general and plastic surgery and dermatology. In addition it is intended to effect stable long term, or permanent hair reduction through selective targeting of melanin in hair follicles (where permanent hair reduction is defined as a long term stable reduction in the number of hairs growing after a treatment regimen)

The Sciton Inc, Hair Removal Laser is a long pulsed, solid state infrared laser. It is intended to deliver laser energy for use in surgical and aesthetic applications requiring the of Removal of Hair folicles. The Hair Removal Laser produces a beam of infrared light at a wavelength of 1064nm. The system consists of: A laser console Internal computer Control panel and display Articulated Arm Footswitch with optional handswitch Scanner and Handpieces with cooling capability

The provided document is a 510(k) summary statement for the Sciton Inc Image Hair Removal Laser. It primarily focuses on demonstrating substantial equivalence to predicate devices and does NOT contain information about acceptance criteria or a study proving that the device meets those criteria.

Therefore, I cannot provide the requested information. The document does not describe:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for a test set, data provenance, ground truth establishment, or expert details.
• Adjudication methods.
• MRMC comparative effectiveness studies.
• Stand-alone performance studies of the algorithm.
• Details about the training set size or how its ground truth was established.

This document is a regulatory submission for premarket notification, which typically focuses on demonstrating that a new device is "substantially equivalent" to an already legally marketed device, rather than detailed clinical study results establishing performance against specific acceptance criteria.

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