(155 days)
Finexel CO2 laser system is intended for use in non-fractionated mode for Incision, Ablation, Vaporization, and Coagulation of Human body soft Tissues in Dermatology, Plastic surgery, Gynecology, Neurosurgery, and in Podiatry.
Finexel CO2 Laser System
I am sorry, but the provided text does not contain any information about a study that proves a medical device meets acceptance criteria, nor does it include a table of acceptance criteria and reported device performance.
The document is an FDA 510(k) clearance letter for the "Finexel CO2 Laser System". It states that the device is substantially equivalent to legally marketed predicate devices for specific indications for use. It lists the general controls and regulations that the manufacturer must comply with.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the information provided.
§ 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.