(144 days)
Cynosure Cellulaze™ Laser is intended for the improvement in the appearance of cellulite as supported by long-term clinical data (at least 6 months with no observed reduction in treatment benefits up to 9 months of observation).
Not Found
The provided document is a 510(k) clearance letter from the FDA for the Cynosure Cellulaze™ Laser. It does not contain the detailed information required to answer the prompt regarding acceptance criteria and performance studies. The letter only states that the device is "substantially equivalent" to legally marketed predicate devices for the "improvement in the appearance of cellulite as supported by long-term clinical data (at least 6 months with no observed reduction in treatment benefits up to 9 months of observation)".
Without the actual 510(k) submission or a summary of safety and effectiveness, it's impossible to extract the specific data requested in the prompt. Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth establishment, or comparative effectiveness 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.