Search Results
Found 1 results
510(k) Data Aggregation
(102 days)
ACULUX, INC.
The XenaLight™ Fiberoptic Illuminator, also known as a lightsource, is attached to a fiberoptic cable transmitting the light to a fiberoptic headlamp, retractor, endoscopic instrument, etc, providing light to the surgical operating field. This light is utilized in many different surgical procedures requiring additional light when overhead lighting is not sufficient.
The XenaLight™ Fiberoptic Illuminator, also known as a lightsource, is attached to a fiberoptic cable transmitting the light to a fiberoptic headlamp, retractor, endoscopic instrument, etc, providing light to the surgical operating field. This light is utilized in many different surgical procedures requiring additional light when overhead lighting is not sufficient.
The fiberoptic cable and/or headlamps are an accessory to the XenaLight™ Fiberoptic Illuminator to transmit the light from the lightsource.
This document is a 510(k) premarket notification letter from the FDA to AcuLux, Inc. regarding their XENALight™ Fiberoptic Illuminator. This is a clearance letter, not a study report, and therefore does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.
The letter acknowledges that the device is substantially equivalent to legally marketed devices and permits AcuLux to market it. It details regulatory information and responsibilities but does not describe any performance studies or acceptance criteria for the device itself.
Therefore, I cannot provide the requested information based on the provided text.
Ask a specific question about this device
Page 1 of 1