www.fdanews.com/articles/192630-laps-positioning-laser-gains-510k-clearance
LAP’s Positioning Laser Gains 510(k) Clearance
September 6, 2019
The FDA has granted LAP 510(k) clearance for the MR-safe version of its Apollo positioning laser used for radiation therapy.
The MR3T high-precision laser is used in radiation therapy for patient positioning during imaging with a magnetic resonance tomograph and in MR-guided radiation therapy with MR-LINAC (linear accelerators).
The device uses a remote control for quick adjustments of the laser’s position and focus. It is available as a single laser or in customized laser bridge versions.