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NaturaLase 980 Laser System is intended for laser assisted lipolysis. The NaturaLase 980 Laser System is intended for surgical applications requiring the ablation, vaporization, excision, incision, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, plastic surgery, dentistry, gastroenterology, general surgery, genitourinary, gynecology, neurosurgery, otolaryngology, orthopedics, ophthalmology, orthopedics, pulmonology, thoracic surgery arthroscopy and podiatry.

The NaturaLase 980 Laser System is a diode laser system with 980 nm wavelength light.

The provided text is a 510(k) summary for the Focus Medical NaturaLase 980 Laser System. It outlines the device's description, indications for use, and its substantial equivalence to predicate devices. However, the document does not contain any information regarding acceptance criteria or a study proving the device meets specific performance metrics.

Therefore, I cannot populate the requested table or answer the specific questions about sample sizes, ground truth, expert qualifications, adjudication methods, or MRMC studies, as this information is not present in the provided text.

The 510(k) process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical performance studies with specific acceptance criteria in the same way a PMA (Pre-Market Approval) or de novo classification would. The "conclusion" section states: "The specifications, indications for use and performance of the NaturaLase 980 Laser System is substantially equivalent to the legally marketed predicate devices. It raises no new issues of safety and effectiveness and should be approved for marketing under the general controls provisions of the Federal Food, Drug, and Cosmetic Act." This indicates that the review focused on comparability rather than new performance testing against set criteria.

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