(106 days)
Podiatry (ablation, vaporization, excision, and coagulation of soft tissue) including: Matrixectomy, periungual and subungual warts, neuromas, and plantar warts. The VelasII is also indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.).
Not Found
The provided document is a 510(k) premarket notification letter for the VELASII Laser System, indicating substantial equivalence to predicate devices. It lists the device's indications for use but does not contain information regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert qualifications for a device performance validation.
Therefore, I cannot provide the requested information from this document. The document primarily focuses on regulatory approval and classification, not on the technical performance specifics or clinical trial data that would demonstrate acceptance criteria being met.
§ 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.