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Medical Devices / Submissions and Approvals

FDA Clears LaserOptek’s Picosecond Laser

Feb. 14, 2019

The FDA granted 510(k) clearance to South Korean devicemaker LaserOptek for its PicoLO picosecond laser.

The compact laser system combines a highly stable pulse duration, energy output and laser induced optical breakdown into one device and can break down and fragment pigments in the patient’s skin.

The device is designed to treat pigmented lesions and can perform tattoo removals, skin rejuvenation and scar corrections.

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