(88 days)
The Ya-Man, Ltd. Laser 21 diode laser system is indicated for the removal of unwanted hair in Fitzpatrick skin types I-IV.
Not Found
I am sorry, but based on the provided text, there is no information available regarding acceptance criteria, device performance studies, or details about the training and test sets and their ground truth establishment.
The document is an FDA 510(k) clearance letter for the "Laser 21" device, indicating that it has been deemed "substantially equivalent" to legally marketed predicate devices for the removal of unwanted hair in Fitzpatrick skin types I-IV.
The letter focuses on regulatory approval and compliance, and does not contain the specifics of any performance studies or validation data that would typically be found in a study report. Therefore, I cannot populate the requested table or answer the specific questions about sample sizes, expert qualifications, adjudication methods, or other study details.
§ 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.