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QUOTED. Aug. 1, 2018. Scott Gottlieb.

Executive Summary

US FDA is asking seven device-makers to defend "vaginal rejuvenation" marketing claims they are making for laser and ablation products without an apparent approval or clearance. See what agency head Scott Gottlieb said about the devices here.

"These products have serious risks and don’t have adequate evidence to support their use for these purposes. We are deeply concerned women are being harmed." –Scott Gottlieb, commissioner, US FDA

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Device Firms’ ‘Vaginal Rejuvenation’ Marketing Claims Spark US FDA Response

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