(17 days)
The Nuvolase 532 Laser System for Ophthalmology is intended for use in retinal and macular photocoagulation and trabeculoplasty.
The Nuvolase 532 Laser System for Ophthalmology is a continuous-wave frequency-doubled diode-pumped Nd:YAG laser system. Treatement beam power output for the system is 50 milliwatts to 1.5 watts at a wavelength of 532 nm. Depending on the delivery device efficiency, the maximum power level may be as much as 2.0 Watts CW. The aiming beam is provided by a red diode laser operating at 670 nm. Exposure durations for the Nuvolase 532 Laser System for Ophthalmology (in seconds) are 0.05, 0.1, 0.25, 0.5, 1.0, and continuous. Delivery of the beam occurs via fiber optic and laser slit lamp.
I am sorry, but the provided text does not contain information on acceptance criteria or a study that proves the device meets specific criteria. The document is a 510(k) summary for the Nuvolase 532 Laser System for Ophthalmology, focusing on its substantial equivalence to a predicate device. It describes the device, its intended use, and confirms that its modifications do not affect its indications for use, materials, method of manufacture, or technology.
Therefore, I cannot provide the requested table and information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.
§ 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.