(88 days)
The PhotoGenica LPIR laser is indicated for hair reduction.
Not Found
I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for the CYNOSURE PhotoGenica LPIR Dermatological Laser. While it states the device's intended use for "hair reduction" and mentions its regulatory classification, it does not contain any information about acceptance criteria, specific studies, sample sizes, expert qualifications, adjudication methods, or multi-reader multi-case studies.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them from the given input. The letter focuses on the FDA's marketing clearance and regulatory compliance, not the technical details of the device's performance studies.
§ 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.