(77 days)
The EsteLuxTM System with the LuxVTM handpiece is intended for the treatment of inflammatory acne (acne vulgaris).
The EsteLux Pulsed Light System with the LuxVTTM handpiece accessory is a light-based medical device designed for treatment of inflammatory acne.
The provided text focuses on the 510(k) summary for the Palomar LuxV™ Handpiece, outlining its classification, intended use, and substantial equivalence to predicate devices for the treatment of inflammatory acne. However, it does not contain information about acceptance criteria, specific study designs, sample sizes for test or training sets, ground truth establishment, expert qualifications, or MRMC studies. The document primarily serves as a regulatory submission for market clearance based on substantial equivalence, rather than a detailed report of a performance study with specific acceptance criteria.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them because the necessary information is not present in the provided text.
Specifically, the document states: "The differences in the specifications of the EsteLux LuxVIM and the ClearTouch do not result in different performance or raise new questions of safety or efficacy. In addition, clinical data was provided to support the safety and efficacy of the LuxV handpiece." This indicates that clinical data was provided, but the details of that data, including the points you've requested, are not included in this 510(k) summary.
§ 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.