(74 days)
The iPulse SmoothSkin BARE Hair Removal System is indicated for the removal of unwanted hair. The iPulse SmoothSkin BARE 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 affer the completion of a treatment regime.
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The provided text is a 510(k) premarket notification clearance letter from the FDA for the "iPulse SmoothSkin Bare Hair Removal System." This document primarily focuses on regulatory approval and does not contain the detailed study information about acceptance criteria and device performance that you are requesting.
Therefore, I cannot fulfill your request using only the information provided. The document states that the FDA reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices, but it does not include the specifics of the clinical study, performance metrics, ground truth establishment, or expert involvement.
§ 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.