(172 days)
The ECHOLASER X4 laser system is indicated for use to necrotize or coagulate soft tissue through interstitial irradiation in medicine and surgery in cardiovascular thoracic surgery (excluding the heart and the vessels in the pericardial sac), dermatology, ear-nose-throat surgery, gastroenterology, general surgery, gynecology, head and neck surgery, orthopedics, pulmonology, radiology, and urology, at a wavelength of 1064nm.
The ECHOLASER X4 is a medical device equipped with a diode laser source emitting at 1064nm wavelength in CW mode. The laser beam is transmitted via optical fibers . The operator can use 1 to 4 (or 1 to 2 in case of two channels model) fibers simultaneously, one independent from the other in both activation and power adjustment. Laser activation is controlled by footswitch.
This document does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. The document is a 510(k) premarket notification from the FDA for the ECHOLASER X4, which is a laser surgical instrument. It details the device's indications for use, its substantial equivalence to a predicate device (K181510), and the fact that the requested change is solely a language revision of the intended use, supported by a reference predicate (K181859).
Since the submission states that no other changes have been made to the existing ECHOLASER X4 and that the technical features, design, performance, and safety are unaffected, no new non-clinical or clinical testing was performed to demonstrate performance against acceptance criteria. The submission relies on the prior clearance of the predicate device.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, or details about studies, sample sizes, ground truth, experts, or adjudication methods, as this information 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.