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The Cutera Flashlamp Tabletop Aesthetic Product is indicated for the treatment of benign pigmented lesions.

The Cutera Flashlamp Tabletop Aesthetic Product consists of a modified console designed to drive the pulsed light hand pieces, which are all existing, FDA cleared devices. The hand pieces are pulsed light devices with a variable emission of 500-1300nm. The delivered wavelength is filtered to various desired wavelength bands within the 500-1300nm range via coated glass filters to eliminate the extraneous wavelengths.

The Cutera Flashlamp Tabletop Aesthetic Product is comprised of five main components:

• · a system console (including software and control electronics);
• a control and display panel;
• · a detachable hand piece with integrated skin cooling;
• · a foot-operated exposure switch (footswitch); and
  · a remote interlock connector (disables emission when treatment room door is opened).

The proximal end of the umbilical cable is semi-permanently attached to the system console and the distal end is permanently attached to the body of the delivery hand piece. This hand piece is removable by either the user or an authorized field service engineer for replacement at the proximal end.

The provided text is a 510(k) summary for the Cutera Flashlamp Tabletop Aesthetic Product, and it explicitly states that no clinical data was required for this submission. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria, device performance studies, sample sizes, expert involvement, or ground truth establishment.

The relevant section states:

VI. Rationale for Substantial Equivalence
The Cutera Flashlamp Tabletop Aesthetic Product shares the same general indications for use, and therefore is substantially equivalent to the currently cleared pulsed light hand piece (K023954) and the currently cleared tabletop console (K042165). No clinical data is required.

This means the device was found substantially equivalent to previously cleared devices based on its shared indications for use, design features, and functional features, rather than requiring a new performance study to meet specific acceptance criteria.

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