A class-action lawsuit was filed against Cynosure, Inc. for allegedly deceptively marketing the MonaLisa Touch laser system as a vaginal rejuvenation device that will increase intimacy and improve sexual function when, according to the complaint, the FDA has not approved the device for such purposes and the device is dangerous and may cause vaginal burns, scarring, and pain. The complaint was originally filed in August 2018 and amended in October 2018. (Three R LLC et al and Cynosure, Inc., Case No. 18-cv-30133, D. Mass.)


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Unauthorized health claims come down in wake of FDA warning letter.


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