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FDA and Low Level Laser Approval

This information is posted on the FDA website regarding the need for clinical data to receive a 510k market approval for Low Level Laser Therapy Medical Devices.   

“Biostimulation lasers, also called low level laser therapy (LLLT), cold lasers, soft lasers, or laser acupuncture devices, were cleared for marketing by FDA through the Premarket Notification/510(k) process as adjunctive devices for the temporary relief of pain. These clearances were based on the presentation of clinical data to support such claims. FDA will consider similar applications for these and other claims with the decision to require clinical data being made on an individual basis, taking into consideration both the device and the claim.”


It is a fact that 10% of all 510(k) clearances given by the FDA require clinical data.