(88 days)
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
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.