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FDA gives clearance for skin resurfacing device
A fractional nonablative laser module, the ResurFX for the Lumenis M22 platform, has been given 510(k) clearance from the Food and Drug Administration.
A fractional nonablative laser module, the ResurFX for the Lumenis M22 platform, has been given 510(k) clearance from the Food and Drug Administration.
The ResurFX module has a 1,565 nm fiber laser and CoolScan scanner to allow homogeneous and uniform patterns of coagulation columns, according to a news release. CoolScan allows clinicians to choose as many as 600 combinations of shapes, sizes and densities. The scanner allows for tissue to “relax” between pulses and protects the skin from overheating.
“The ResurFX module with the CoolScan scanner allows me to treat patients faster and with greater efficacy, without having to compromise on patient comfort and safety,” Mitchel P. Goldman, M.D., volunteer clinical professor of dermatology, University of California, San Diego, said in the statement.
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