Search Results

The ISOLUX America's Surgical Headlight is indicated for illumination purposes from an illuminator to a headlight to aid in providing illumination to body cavities during examinations or surgical procedures.

Not Found

The provided document is a 510(k) Pre-market Notification letter from the FDA to Isolux America regarding their ISOLUX Fiber Optic Surgical Headlight. This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The letter states that the FDA has determined the device is "substantially equivalent" to legally marketed devices, indicating that it does not require new efficacy or safety studies to be approved for market. Therefore, the detailed information requested regarding specific acceptance criteria, performance data, sample sizes, expert qualifications, adjudication methods, or comparative effectiveness studies is not present in this regulatory correspondence.

The document primarily covers:

• Device Name: ISOLUX Fiber Optic Surgical Headlight
• Regulatory Class: II
• Product Code: FST
• FDA Determination: Substantially equivalent to pre-amendments devices.
• Indications for Use: "illumination purposes from an illuminator to a headlight to aid in providing illumination to body cavities during examinations or surgical procedures."

Ask a specific question about this device