(30 days)
The BRAUN Silk.expert Mini Hair Removal Device is indicated for the removal of unwanted hair. The BRAUN Silk.expert Mini is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.
Not Found
This document is an FDA 510(k) clearance letter for the Braun Silk.expert Mini, a hair removal device. It primarily focuses on regulatory approval and does not contain detailed information about specific acceptance criteria or the study data proving the device meets those criteria.
Therefore, I cannot extract the requested information (table of acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details) from the provided text. The document confirms the device's clearance for "permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime," but it does not elaborate on the specific study details that validated this claim.
§ 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.