(84 days)
SureScan may be used for a variety of soft tissue ablation procedures where precise removal is required to minimize damage to adjacent or underlying tissue layers.
SureScan converts any CO2 laser, pulsed or CW, into a sophisticated aesthetic surgery laser system for performing a wide variety of laser procedures. It comes equipped with six different patterns in 26 different sizes. It automatically adjusts the scan speed to ensure uniform laser ablation which eliminates charring and thermal damage. The collimated beam ensures constant power density and tissue removal at any working distance. The SureScan has an adjustable spot overlap density for more precision and control. The Scan outline and size are clearly displayed on the tissue, allowing precise placement of the laser energy and subsequent scan shapes.
This 510(k) submission for the SureScan Laser Accessory describes a device that "converts any CO2 laser, pulsed or CW, into a sophisticated aesthetic surgery laser system for performing a wide variety of laser procedures." The document focuses on the device's technological characteristics and intended use, rather than a clinical study with acceptance criteria and performance metrics.
Therefore, the provided text does not contain the information required to populate a table of acceptance criteria and reported device performance, nor details about a study proving the device meets acceptance criteria.
The document, being a 510(k) summary from 1996, primarily focuses on demonstrating substantial equivalence to predicate devices (Lasersonics Parascan and Coherent Computerized Pattern Generator) based on technological characteristics and intended use, rather than a detailed performance study with defined acceptance criteria typically seen in more recent submissions involving novel AI or diagnostic devices.
The information you are requesting about sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment would generally be found in a clinical or performance study section, which is not present in this 510(k) summary.
§ 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.