# Uvision360, Inc.

- Location (FDA's records): Raleigh, NC
- FDA decisions: 4 (2018–2021): 4 510(k) clearances
- Product codes: FAJ (2), HIH (2)
- 510(k) review time since 2016: median 71 days, against 91 for FDA's reviews in the same codes and years (2 of 3 faster)
- Predicates its devices cite: 5 (3 its own); citations of its devices by later devices: 3 (3 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Vision-Sciences, Inc.: 2 (https://510kreport.com/company/vision-sciences)

## Its most-cited devices
- K192278: Luminelle DTx Hysteroscopy System, Luminelle Dx 360 Rotatable Disposable Sheath (Diagnostic) (2019), cited by 1
- K181909: Luminelle DTx Hysteroscopy System (2018), cited by 1
- K190827: Luminelle DTx Hysteroscopy System, Luminelle 360 Rotatable Sterile Disposable Sheath Rigid (2019), cited by 1

## Recent decisions
- K210512: LUMINELLE DTx System (Jun 30, 2021)
- K192278: Luminelle DTx Hysteroscopy System, Luminelle Dx 360 Rotatable Disposable Sheath (Diagnostic) (Nov 1, 2019)
- K190827: Luminelle DTx Hysteroscopy System, Luminelle 360 Rotatable Sterile Disposable Sheath Rigid (Jun 6, 2019)
- K181909: Luminelle DTx Hysteroscopy System (Aug 16, 2018)

Source page: https://510kreport.com/company/uvision360