(46 days)
The coupler interfaces at the distal knuckle of the CO2 Laser and either the operating laparoscope or second puncture tubes allowing direct delivery of the focused beam.
CO2 Laser Coupler
This is a 510(k) clearance letter from the FDA for a CO2 Laser Coupler. It indicates legal marketing of the device based on substantial equivalence to a predicate device. However, this document does not contain any information regarding specific acceptance criteria, device performance studies, or clinical trial data.
To answer your request, I would need a different type of document, such as a summary of safety and effectiveness, a clinical study report, or detailed performance specification documents that would typically accompany a regulatory submission if performance data was required for the clearance.
Therefore, for the provided input, I cannot fill out the requested table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement.
§ 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.