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Medical Devices / Submissions and Approvals

MT.DERM’s Microneedling Device Receives FDA Clearance

Aug. 9, 2019

The FDA has granted German devicemaker MT.DERM 510(k) clearance for its microneedling device for treating acne scars and facial wrinkles.

The lightweight handpiece includes adjustable speed modes and it uses a separate power unit for to prevent overheating.

Each treatment session can be completed in less than hour and the treatment requires little to no recovery time, the company said.

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