(106 days)
Ice Cooling IPL Hair Removal Device with sapphire treatment window is indicated for the removal of unwanted hair. The device 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
The provided text is a 510(k) premarket notification letter from the FDA for an "Ice Cooling IPL Hair Removal Device." This document serves as an approval letter, stating that the device is substantially equivalent to legally marketed predicate devices.
However, the provided text DOES NOT contain the specific information requested in your prompt regarding acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, or multi-reader multi-case studies.
This type of FDA letter typically refers to information already submitted by the manufacturer in their 510(k) application. To answer your questions, one would need to review the actual 510(k) submission, which is not included in the provided text.
Therefore, I cannot fulfill your request with the given input. The document confirms market clearance but does not detail the technical studies and data that led to that clearance.
§ 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.