(285 days)
694 nm nanosecond (QS mode)
Indicated for: Tattoo removal: Suggested for blue, sky blue, black, green and violet ink; Pigmented lesion removal (benign): - Cafe au lait spot - Ephalides, solar lentigo lentigines - Becker Nevus - Ota and Ito Nevus - Nevus spilus - Mongolian spot.
694 nm picosecond (PS mode)
Indicated for treatment of benign pigmented lesions on patients with Fitzpatrick skin types I-III.
Not Found
Based on the provided text, there is no information about acceptance criteria, device performance, a study to prove acceptance criteria, sample sizes, data provenance, expert involvement, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, or how ground truth was established for the Rosso device.
The document is an FDA 510(k) clearance letter for the Rosso laser surgical instrument. It states that the device is substantially equivalent to legally marketed predicate devices and lists its "Indications for Use." This type of document confirms regulatory clearance but does not typically include the detailed technical study information that would be found in a clinical study report or a more comprehensive technical submission.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or details about a study, as this information is not present in the provided text.
§ 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.