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The THL1 Laser is indicated for use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin.

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This document is a 510(k) clearance letter from the FDA for a medical device (Erchonia® THL1 Laser). It states that the device is substantially equivalent to a legally marketed predicate device. This type of document does not contain the detailed information necessary to answer your specific questions about acceptance criteria and a study proving device performance.

A 510(k) submission typically includes a summary of performance data, but the full study details, acceptance criteria, sample sizes, ground truth establishment, and MRMC study results are not usually part of the public-facing clearance letter. These are found in the original 510(k) submission document itself, which is often much more extensive.

Therefore, based only on the provided text ({0}, {1}, {2}), I cannot provide a table of acceptance criteria, reported device performance, or details about the study. The document primarily focuses on the regulatory clearance and indications for use.

To answer your questions, I would need access to the actual 510(k) submission (K100509) or its summary, which would include the clinical or performance data that supported the substantial equivalence claim.

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