(76 days)
The MedArt® 455/910-series Scanner will be used to manipulate and place a pulsed beam of light for use in dermatology for treatment of ablation, vaporization or coagulation of soft tissue.
Not Found
This document is a 510(k) clearance letter from the FDA for a medical device called the "MedArt® 455/910 Series Scanner." It does not contain information about acceptance criteria, device performance, study details, or ground truth establishment.
A 510(k) clearance letter indicates that the FDA has determined the device is "substantially equivalent" to a predicate device already on the market, meaning it has the same intended use and technological characteristics as a legally marketed device or has different technological characteristics but does not raise different questions of safety and effectiveness. This determination is generally based on the manufacturer providing sufficient information to demonstrate substantial equivalence, which often includes performance data, but the letter itself does not detail these studies or their results.
Therefore, I cannot provide the requested information based on the provided text. The document only states the device's regulatory classification, its trade name, and its indications for use.
§ 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.