(27 days)
The Braun Skin i.expert Hair Removal Device is indicated for the removal of unwanted hair. The Braun Skin i.expert 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
I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study details, or ground truth establishment for the Braun Skin i.expert device. The document is an FDA 510(k) clearance letter confirming that the device is substantially equivalent to a legally marketed predicate device and outlines general regulatory information and compliance requirements. It also includes the official Indications for Use statement for the device. Details regarding the technical aspects of the device's performance, the studies conducted, and the methodology for establishing ground truth are not present in this document.
§ 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.