(90 days)
The LS-905 FiberChoice™ Adapter System is indicated for use for non-standard laser output ports for lasers manufactured by Laserscope. The LS-905 FiberChoice™ Adapter System is designed to allow owners of Laserscope lasers to connect Laser Peripherals, Inc. 510(k) cleared laser fibers to their lasers. The adapter may be used in each surgical specialty or procedure along with Laser Peripherals laser fibers for which compatible Laserscope lasers have received regulatory clearance.
Not Found
The provided document {0} - {2} is a 510(k) clearance letter for the LS-905 FiberChoice Adapter System. It states that the device is substantially equivalent to legally marketed predicate devices and outlines the general controls and regulations applicable to the device. However, it does not contain information about acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert qualifications. Therefore, I cannot generate the requested information based on 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.