Actions and outcomes of TGA about laser energy based devices that are used for vaginal rejuvenation.
Based on extensive reviews and expert opinions, all energy-based devices intended for the use of vaginal rejuvenation sold in Australia have been cancelled.
"All regulatory decisions made during this review were made on an individual basis. All decisions were based on the evidence submitted by sponsors, expert advice, and literature.
Some ARTG entries include a range of different devices and handpieces used for different purposes including dermatology and other specialties. Where multiple devices were supplied under one ARTG entry, we have only cancelled the devices that are intended for the use of vaginal rejuvenation. The devices used for other applications can continue to be used."