(159 days)
Meladine™ Natural Melanin Enhancer is indicated as a topical pretreatment prior to undergoing laser hair removal for patients suffering from unwanted, non-pigmented hair growth (white, grey, light blonde) who are unlikely to experience hair reduction with laser treatment alone.
Meladine™ Natural Melanin Enhancer (Accessory to Surgical Laser Instruments used for Hair Removal)
This document is a 510(k) premarket notification letter from the FDA regarding the Meladine™ Natural Melanin Enhancer. It indicates substantial equivalence to a predicate device and provides regulatory information for marketing. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, ground truth types, or training set details.
Therefore, I cannot provide the requested information based on the provided text. The document is primarily a regulatory approval letter, not a technical report detailing a study.
§ 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.