# Uvision360, Inc.

> Medical device manufacturer record on deviCERTS, compiled from public registries. Uvision360, Inc. is a medical device manufacturer, with 14 devices listed in FDA GUDID and FDA 510(k) (FDA Class II and I) as of 14 Nov 2026.

- Canonical page: <https://devicerts.com/manufacturers/uvision360-inc>
- Country: United States (FDA applicant, unverified)
- Role: Manufacturer

## Figures

- Devices: 14
- FDA recalls (matched to the firm by name): 0

## Registry facts

*Every device of the manufacturer. A device listed in two registries counts in both.*

- Registries: FDA GUDID 10, FDA 510(k) 4
- Device classes: FDA Class II 13, FDA Class I 1

## Devices

The first 14 of 14, in the order of the canonical page, which lists them all.

- [Uvision Hysteroscope Cable 20050](https://devicerts.com/devices/uvision-hysteroscope-cable-20050) · Class II · GUDID · status: Active
- [LUMINELLE DTx 360 Rotatable Disposable Sheaths LUMDTx-360](https://devicerts.com/devices/luminelle-dtx-360-rotatable-disposable-sheaths-20020) · Class II · GUDID · status: Active
- [LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy) LUMBx-360 DOWN](https://devicerts.com/devices/luminelle-bx-360deg-rotatable-disposable-sheath-biopsy-20085) · Class II · GUDID · status: Active
- [LUMINELLE Aspirator LUM-A](https://devicerts.com/devices/luminelle-aspirator-20081) · Class I · GUDID · status: Listed
- [LUMINELLE DTx Hysteroscopy System LumDTX-A](https://devicerts.com/devices/luminelle-dtx-hysteroscopy-system-20030) · Class II · GUDID · status: Active
- [LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy) LUMBx-360 UP](https://devicerts.com/devices/luminelle-bx-360deg-rotatable-disposable-sheath-biopsy-20080) · Class II · GUDID · status: Active
- [Uvision Hysteroscope LUMDTx-A1](https://devicerts.com/devices/uvision-hysteroscope-20010) · Class II · GUDID · status: Active
- [LUMINELLE Dx 360o Rotatable Disposable Sheath (Diagnostic) LUMDx-360](https://devicerts.com/devices/luminelle-dx-360o-rotatable-disposable-sheath-diagnostic-20070) · Class II · GUDID · status: Active
- [LUMINELLE DTx 360 Rigid Rotatable Disposable Sheath LUMDTx-360R](https://devicerts.com/devices/luminelle-dtx-360-rigid-rotatable-disposable-sheath-20060) · Class II · GUDID · status: Active
- [Luminelle DTx Control Hub 20012](https://devicerts.com/devices/luminelle-dtx-control-hub-20012) · Class II · GUDID · status: Active
- [Luminelle DTx Hysteroscopy System](https://devicerts.com/devices/luminelle-dtx-hysteroscopy-system-faj) · ref K181909 · Class II · 510(k) · status: Active · decision 2018-08-16
- [LUMINELLE DTx System](https://devicerts.com/devices/luminelle-dtx-system-faj) · ref K210512 · Class II · 510(k) · status: Active · decision 2021-06-30
- [Luminelle DTx Hysteroscopy System, Luminelle 360 Rotatable Sterile Disposable Sheath Rigid](https://devicerts.com/devices/luminelle-dtx-hysteroscopy-system-luminelle-360-rotatable-st-hih) · ref K190827 · Class II · 510(k) · status: Active · decision 2019-06-06
- [Luminelle DTx Hysteroscopy System, Luminelle Dx 360 Rotatable Disposable Sheath (Diagnostic)](https://devicerts.com/devices/luminelle-dtx-hysteroscopy-system-luminelle-dx-360-rotatable-hih) · ref K192278 · Class II · 510(k) · status: Active · decision 2019-11-01

## Source and citation

- Cite as: Uvision360, Inc. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/uvision360-inc (data as of 2026-11-14).
- Data sources: [FDA GUDID](https://accessgudid.nlm.nih.gov/), [FDA 510(k)](https://open.fda.gov/apis/device/510k/)
- FDA recall data as of: 2026-11-01
- Data as of: 2026-11-14
- JSON: <https://devicerts.com/manufacturers/uvision360-inc.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/manufacturers/uvision360-inc
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.