(34 days)
Scanning device attachment used with the Centauri™ Er:YAG Laser System for use in Dermatology for treatment of soft tissue, including incision, excision, hemostasis, ablation and vaporization of tissue.
Scanning device attachment used with the Centauri™ Er:YAG Laser System
The provided text is an FDA 510(k) clearance letter for the dERmium Scanner for the Centauri™ Er:YAG Laser System II. This document primarily focuses on the regulatory clearance for marketing the device based on substantial equivalence to a predicate device. It defines the intended use and regulatory classification.
However, the document does not contain any information regarding specific acceptance criteria, device performance metrics, or study details such as sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies.
Therefore, I cannot provide a detailed answer to your request in the format you specified. The information you are seeking about acceptance criteria and the study that proves the device meets them 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.