Search Results

The SunLase 800P is indicated for incising, excising and coagulating intraoral soft tissue, including the marginal and interdental gingiya. This includes incising, excising and coagulating the epithelium lining, the free or marginal gingiva, sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket).

Not Found

I apologize, but this document contains a letter from the FDA regarding a 510(k) clearance for the Sunlase 800P Laser System. It does not contain any information about acceptance criteria or a study proving device performance in the way you've outlined in your request (e.g., test sets, ground truth, expert qualifications, MRMC studies).

The document is a notification of substantial equivalence for a medical device, which means the device was found to be as safe and effective as a legally marketed predicate device. The 510(k) process typically doesn't involve the detailed performance study data you're asking for in this format, especially for devices cleared in 1999.

Therefore, I cannot fulfill your request with the provided input.

Ask a specific question about this device