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Off-Label Use

MonaLisa Touch Machine

What should a company do if it’s under contract to lease a very expensive device and then receives an official warning not to use the device for its purposes? The complaint for this class action claims that Cynosure, Inc. has touted its MonaLisa Touch device as a “vaginal rejuvenator” but that the Food and Drug Administration (FDA) has issued a warning not to use the device for that purpose.