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The Sapphire O/E oral examination light is intended for use by a dentist or qualified health-care provider as an adjunct to traditional oral examination by white light to enhance the visualization of oral mucosal abnormalities that may not be apparent or visible to the naked eye, such as oral cancer or pre-malignant dysphasia. Sapphire O/E oral examination light is further intended to be used by a surgeon to help identify diseased tissue around a clinically apparent lesion and thus aid in determining the appropriate margin for surgical excision.

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The provided text primarily focuses on the FDA's regulatory decision regarding the Sapphire™ O/E Oral Examination System and does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria.

The document is a 510(k) premarket notification approval letter, indicating that the device has been deemed substantially equivalent to a predicate device. It defines the device's indications for use but does not delve into the specific performance studies, acceptance criteria, or statistical details of those studies.

Therefore, I cannot provide the requested information based on the given input. The document is a regulatory approval notice, not a study report.

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