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The laser system DERMABLATE ER:YAG LASER SYSTEM is intended for laser assisted site preparation for hair transplantation. This indication is in addition to previously cleared indications.

The laser system DERMABLATE ER:YAG LASER SYSTEM is restricted to sale to or use by licensed professionals in the United States.

The laser system DERMABLATE ER:YAG LASER SYSTEM is an Erbium:YAG laser with a wavelength of 2.94µm.

The provided text does not contain information about acceptance criteria or a study proving the device meets them. The document is a 510(k) summary for the AESCULAP-MEDITEC GMBH DERMABLATE ER:YAG LASER SYSTEM, which focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance against acceptance criteria through a study.

Specifically, the document states:

• "Performance data: None. The specifications and intended uses of the laser system DERMABLATE ER:YAG LASER SYSTEM are the same or very similar to those of claimed predicate devices. Because that, performance data were not required."

Therefore, I cannot fill out the requested table and information.

If there were performance data, the table would look like this:

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