(31 days)
The BRAUN Silk.expert Pro 3 Hair Removal Device is indicated for the removal of unwanted hair. The BRAUN Silk.expert Pro 3 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 Pro 3 Hair Removal Device, Model 6032. It does not contain the detailed information about acceptance criteria, study design, or performance metrics that would be expected in a clinical study report or a more comprehensive summary of safety and effectiveness data.
Therefore, I cannot provide the requested information based solely on the provided text. The document confirms that the device is cleared for marketing based on substantial equivalence, and it specifies the Indications for Use. However, it does not include the detailed scientific evidence that supports these indications.
§ 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.