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Medical Devices / Submissions and Approvals

FDA Clears Soliton’s Tattoo Removal Accessory for Q-Switched Laser

May 30, 2019
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Soliton’s Rapid Acoustic Pulse (RAP) device for removing black ink tattoos has been cleared by the FDA as an accessory to the devicemaker’s 1064 nm Q-Switched laser for use in patients with Fitzpatrick skin types one through three.

The device converts electric power into acoustic shockwaves that work at a rate of 100 pulses per second in very brief bursts.

The shockwaves do not cause tissue or heat damage, avoiding bruising, downtime for recovery and the sensation of pain.

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