(21 days)
The ScatterFree™ Lateral Emitting Fiber is intended for use in General, Urological, OB-GYN, Orthopedic and ENT laser surgical procedures for cutting, vaporizing or coagulating in any soft tissue application for which compatible Nd:YAG, KTP and Ho:YAG lasers have been cleared.
ScatterFree™ Lateral Emitting Fiber
The provided text is a 510(k) clearance letter from the FDA for the ScatterFree™ Lateral Emitting Fiber. It describes the device's intended use and states that it has been found substantially equivalent to predicate devices. However, this document does not contain any information regarding specific acceptance criteria, a study proving device performance against those criteria, or details about ground truth, sample sizes, or expert adjudication.
Therefore, I cannot provide the requested information from the given input. The document is administrative in nature, confirming regulatory clearance, rather than a scientific study report.
§ 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.