(14 days)
The Aurora DS is indicated for the removal of unwanted hair from skin types I-VI, and to effect stable long-term, or permanent, hair reduction
The Aurora DS is a device that is used for the removal of unwanted hair from skin types I-VI, and to effect stable long-term, or permanent, hair reduction. The Aurora DS treatment is based on a principle of selective thermolysis. According to this principle, parameters of optical and RF energy (spectrum, exposure duration and energy density) are chosen (and optimized) to selectively damage (destroy) vascular and pigmented lesions without damaging the surrounding tissues.
The provided text describes a 510(k) summary for the Syneron Medical Ltd. Aurora DS / DS Applicator, which is a device used for hair removal. This document is a regulatory submission for a device modification, specifically changing the light spectrum output.
Based on the provided text, there is no information available regarding acceptance criteria or a study that proves the device meets those criteria, as typically understood for AI/ML device performance.
The document states: "The modifications to the Aurora DS do not affect the intended use or alter the fundamental scientific technology of the device. The only device modification is changing the light spectrum output. There are no labeling changes that affect the intended use of the device. The device modifications raise no new issues of safety or effectiveness."
This suggests that the 510(k) submission is for a minor modification that is not expected to change the device's performance from its previously cleared version. Therefore, a new, extensive performance study with acceptance criteria, as one would expect for a novel or significantly modified device, is not presented or required in this particular 510(k) summary. The FDA's letter confirms substantial equivalence to a predicate device, which means the safety and effectiveness are considered to be similar to an already legally marketed device.
Therefore, I cannot provide the requested table and information, as the input document does not contain details about specific performance acceptance criteria or a study proving those criteria for the modified device.
§ 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.