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The laser system Ruby Star (operating in normal use) is intended to remove unwanted body hair.

The laser system Ruby Star (operating in Q-Switch mode) is indicated for cutting, vaporization, or ablation of soft tissue. This includes tattoo removal and treatment of benign pigmented lesions.

Some examples of pigment lesions are:

Lentigines, Cafe-au-lait-blotches, Ephalides, Benign Naevi such as Nevus of Ota, Naevus of Ito, Epidermal naevi, Congenital naevi, Becker's naevi, Blue naevus, Naevus spilus, and Mongolian spot.

The laser system Ruby Star is restricted to sale or use by licensed professionals in the United States

The laser system RubyStar operates as a normal pulse or as a Q-Switched ruby laser which emits a beam of coherent light at 694 nanometers. In Q-Switched mode the beam has much shorter pulse duration than in the normal pulse mode.

The provided text states: "Performance data: None. The specifications and intended uses of the laser system RubyStar operating in Q-Switch or normal mode are the same or very similar to those of claimed predicate devices. Because of this, performance data were not required."

Therefore, the following information cannot be extracted from the document:

• Table of acceptance criteria and reported device performance
• Sample size used for the test set and data provenance
• Number of experts used to establish ground truth for the test set and their qualifications
• Adjudication method for the test set
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done or its effect size
• Whether a standalone (algorithm only) performance study was done
• The type of ground truth used
• The sample size for the training set
• How the ground truth for the training set was established

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