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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.).

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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.

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The VelasII Therapy Laser System is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with minor arthritis, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation.

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The provided text is a 510(k) premarket notification approval letter for the VelasII Therapy Laser System. It does not contain any information about acceptance criteria or supporting studies that demonstrate the device meets these criteria.

Therefore, I cannot provide the requested information. The document focuses on the regulatory approval process based on substantial equivalence to a predicate device, rather than detailed performance study results.

Ask a specific question about this device