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The Dermablate laser is intended for coagulation, vaporization, ablation, or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery), oral surgery, and ophthalmology (skin around the eyes).

The Dermablate laser is an erbium: YAG laser operating at 2.94 microns and with a maximum pulse energy of 2 J.

The provided text describes a 510(k) summary for the DERMABLATE ERBIUM LASER SYSTEM. It explicitly states that no performance data, acceptance criteria, or studies were required for this device.

Here's why, based on the provided text:

• The summary in section {1} states: "None. The specifications and intended uses of the Dermablate laser are the Performance Data: same or very similar to those of the claimed predicate devices, including the MCL 29 Dermablate. There are no significant differences between the devices under conditions of intended use. Because of this, performance data were not required."

Therefore, I cannot populate the requested information regarding acceptance criteria and studies. The device's clearance was based on its substantial equivalence to legally marketed predicate devices without the need for new performance testing.

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