(229 days)
ORskin Blue is intended for incision, vaporization, ablation, hemostasis, and coagulation of soft tissue.
Not Found
I apologize, but the provided text is a 510(k) clearance letter from the FDA for a device named "ORskin Blue," a laser surgical instrument. This document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any of the other specific details requested in your prompt regarding a study proving the device meets acceptance criteria.
The letter confirms that the device is substantially equivalent to a legally marketed predicate device and outlines regulatory compliance requirements. It does not provide the technical or clinical study data you are asking for. Therefore, I cannot extract that information from this document.
§ 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.