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# UVision60 Luminelle DTx Hysteroscopy Cleared
- URL: https://www.fdaweb.com/uvision60-luminelle-dtx-hysteroscopy-cleared/
- Published: 2018-08-21T12:00:00.000Z
- Updated: 2026-09-15T00:27:06.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5142168

FDA has cleared a UVision360 510(k) for the Luminelle DTx Hysteroscopy for use in both hysteroscopy and cystoscopy procedures. The device allows physicians to see the uterus’ internal lining from an “optimal distance with clarity thus enabling identification of suspicious tissue, perform a biopsy under visualization, and offer a potentially faster diagnosis, treatment and recovery time for the patient,” according to the company. The device features a flexible 2.0 mm scope and a two-part single use protective sheath. “The introducer fully encompasses the scope, thereby protecting the scope and minimizing the chance of contact with bodily fluids by reducing scope contamination,” it says. It includes an operative channel to enable therapeutic procedures, such as biopsies and polypectomies to be completed with visualization.”