FDA Releases Guidance, Rule on Low-Level Lasers

May 19, 2011
The FDA has released a guidance and final rule classifying low-level laser systems for aesthetic use into Class II with special controls. The down-classification comes after Erchonia Medical sought to have its noninvasive body-contouring device, the Zerona, cleared through the de novo process, which is for devices that don’t have a predicate but are considered low risk. The FDA recommends preclinical testing demonstrate a low-level laser system for aesthetic use meets all design specification and performance requirements. Testing should demonstrate the accuracy of the method for targeting the region of interest and, if applicable, for monitoring treatment progress or results.
International Medical Device Regulatory Monitor