(29 days)
The Laser Peripherals bare laser fiber is intended for use in laser surgical procedures for cutting, coagulating, or vaporizing in any soft tissue application for which compatible Nd: YAG, KTP and Diode lasers have been cleared.
Laser Peripherals Bare Laser Fiber
This is an FDA Premarket Notification (510(k)) letter for the Laser Peripherals Bare Laser Fiber. It is a clearance letter, not a study report. The document states that the device is substantially equivalent to legally marketed predicate devices. Therefore, it does not contain the detailed information requested regarding acceptance criteria, study design, sample sizes, ground truth establishment, or expert involvement for a de novo or PMA submission.
The document essentially states that since the device is substantially equivalent to already cleared devices, a new study to prove device performance against acceptance criteria isn't required in the same way it would be for a novel device.
Therefore, I cannot provide the requested 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.