(78 days)
The Nuvo-Lase 660 Laser System is intended for use in the treatment of selected vascular and pigmented lesions of the skin. Laser light is used to photocoagulate tissue based on the absorption characteristic of the targeted chromophore within the tissue. The Nuvo-Lase 660 Laser System is intended for in use the treatment of selected pigmented and vascularized lesions of the skin. Representative indications for use are: For vascular lesions: (Green - 532 nm) 1. Capillary Hemangioma (port wine hemangioma) 2 . Strawberry hemangioma 3. Telangiectasia 4 . Rosacea For pigmented lesions: (Green - 532 nm). 1. Freckles 2. Age Spots 3. Cafe-au-lait 4 . Lentigo
The Nuvo-Lase 660 Laser System submission covers all of the internal parts, subassemblies and components as well as the completed device. The Nuvo-Lase Model 660 is a continuous wave frequency-doubled Nd:YAG laser system with output at 532 nm. Treatment beam output for the Nuvo-Lase 660 laser 3 Watts continuous wave at 532 nm. The aiming beam is provided by an adjustable intensity incoherent white light source. Exposure times for the Nuvo-Lase 660 Laser System (in seconds) are 0.02, 0.05, 0.1, 0.25, 0.5, 1.0, and continuous. Laser activation occurs by footswitch. Overall weight of the dimensions of 10 X 14 X 5 inches (25 X 36 X 13 Cm). The electrical power requirement is 115 VAC 15 amp single phase. The system is air-cooled by fans. Accessories available for use with the Nuvo-Lase 660 Laser include a focusing handpiece with interchangeable guide tips and/or the Hexascan Mark II. The Nuvo-Lase 660 Laser System is not a computer controlled device.
The provided text is a medical device summary for the Nuvo-Lase 660 Laser System. It focuses on regulatory information, device description, and intended use, particularly for vascular and pigmented lesions.
It does not contain information about acceptance criteria, device performance metrics, or any study details (sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, or training set information).
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or information about a study that proves the device meets acceptance criteria, 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.