(90 days)
The laser modes are intended for retinal photocoagulation and laser trabeculaplasty. Delivery devices available are the Endoprobe for intraocular endolaser surgery, and the Laser Indirect Ophthalmoscope Plus (LIO+) for transpupillary laser delivery for patients in the supine position.
The Millennium™ Laser Photocoagulator System is a Class 4 laser. The system is made up of three separate components that are required to interface with each other in order to allow laser emission, They are the Laser Module, Multifunctional Foot Control with laser switch and the junction box. In order for the Millennium™ Microsurgical System to operate the Lascr Module, the system must have laser enabled software. The software includes functions to recognize the laser module as a network node and provides the graphical user interface.
The provided text is a 510(k) summary for the Millennium™ Laser Photocoagulator System. This document focuses on establishing substantial equivalence to a predicate device (IRIS Medical® OcuLight® GL Laser System) rather than presenting a performance study with acceptance criteria in the context of AI/ML or diagnostic devices.
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC/standalone studies is not available in the provided text.
The document describes the device's components, intended use, and similarities/differences with the predicate device, ultimately receiving an FDA clearance based on substantial equivalence. This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than proving performance against specific quantitative criteria through a clinical or technical study as might be done for novel diagnostic or AI-powered devices.
§ 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.