# K242924: OPXION Optical Skin Viewer (OPXSV1-01F)

- Pathway: 510(k) (Traditional)
- Applicant: Opxion Technology, Inc.
- Decided: Jun 23, 2025 after 272 days
- Product code: NQQ (System, Imaging, Optical Coherence Tomography (Oct))
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K093520 (2010). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093520: Vivosight Topical Oct System, Michelson Diagnostics, Ltd. (2010) Summary page 6.

## Indications for use
OPXION Optical Skin Viewer is a non-invasive imaging system intended to be used for real-time visualization of the external tissues of the human body. The two-dimensional, cross-sectional, three-dimensional, and en-face images of tissue microstructures can be obtained.

Source page: https://510kreport.com/device/K242924
Methodology: https://510kreport.com/methodology