(213 days)
The left handpiece (560nm) of the SmoothCool is indicated for the treatment of benign pigmented lesions (including, but not limited to solar lentigines, ephilides, mottled pigmentation) and benigh vascular lesions (diffuse redness). The right handpiece (700nm) is indicated for hair removal (permanent hair reduction).
SmoothCool
I am sorry, but based on the provided text, I cannot provide a description of the acceptance criteria and the study that proves the device meets the acceptance criteria. The text is a letter from the FDA regarding a 510(k) premarket notification for a device called "Smoothcool." It states that the device is substantially equivalent to legally marketed predicate devices and outlines general controls provisions and other regulatory information.
However, the letter does not contain any information about specific acceptance criteria for the device's performance, nor does it describe any studies conducted to prove the device meets such criteria. It only lists the "Indications for Use" of the SmoothCool device.
§ 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.