Search Results

To provide light for fiberoptic cables and instruments. Provide light for instrumentation via fiberoptic cables for use in surgical fields. For example: lightsource attaches to fiberoptic cable which is then attached to a headlight or Endoscope. The lightsource supplies light for the headlight or Endoscope.

Lightsource or illuminator M-300

The provided text is a 510(k) clearance letter from the FDA for a device called "Cuda Products Corp. Model M300 (M-300) Lightsource". This document is a regulatory approval and does not contain information about acceptance criteria, study design, or performance metrics that would typically be found in a clinical study report.

Therefore, I cannot extract the information required in your request from this document. The document primarily states that the device is substantially equivalent to legally marketed predicate devices and is approved for marketing. It specifies the product code, regulatory class, and indications for use, but no performance data.

Ask a specific question about this device