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FDAnews Device Daily Bulletin

LAP’s Positioning Laser Gains 510(k) Clearance

Sept. 9, 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.

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