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# Hologic’s Cynosure Unit Suspends Marketing of Vaginal Device
- URL: https://www.fdaweb.com/hologics-cynosure-unit-suspends-marketing-of-vaginal-device/
- Published: 2018-08-13T12:00:00.000Z
- Updated: 2026-09-15T00:25:19.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5142092

Hologic’s Cynosure division has suspended marketing and distribution of its TempSure Vitalia handpiece and probe, which is used for heating vaginal tissue, due to FDA concerns regarding “vaginal rejuvenation” procedures using energy-based devices ([see earlier story](https://www.fdaweb.com/fda-cautions-about-vaginal-rejuvenation-devices/)). Last month, FDA warned that using energy-based medical devices to perform vaginal rejuvenation, cosmetic vaginal procedures, or non-surgical vaginal procedures to treat symptoms related to menopause, urinary incontinence, or sexual function may be associated with serious adverse events. While FDA did not mention Vitalia in its warning, Cynosure says it has carefully considered the agency’s broader concerns and elected to suspend marketing of the devices until it has confirmed they meet all regulatory requirements for devices in this category.