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Maquet Medical Systems obtains FDA 510(k) approval for new surgical lighting system

US-based Maquet Medical Systems has obtained 510(k) approval from the US Food and Drug Administration (FDA) for the VOLISTA surgical lighting system.

Incorporating Maquet Medical Systems’ Luminance Management Device (LMD) technology, the VOLISTA system offers the option of three color temperatures (3900, 4500 or 5100°K) to adapt the illumination based on the surgery that is being performed.

The company claims that it is the first lighting system to provide surgeons a clear and accurate view of anatomical structures during surgery, minimal peripheral reflections and assurance of equivalent light levels.

Surgeons can also easily configure the equipment according to their needs of the procedure.

Maquet Medical Systems president Raoul Quintero noted the VOLISTA system is another addition to the company’s portfolio of hospital lighting that enables surgeons to configure the operating room in the way they find most useful and productive, based on the procedure that they are conducting.

"Furthermore, the VOLISTA system allows operating rooms to become more versatile and used for a wide variety of procedures, ultimately helping to ensure that each operating room in the hospital is being maximized," Quintero added.

VOLISTA surgical lighting system is an extension of the TRIOP light assembly.