# K080788: Vivascope System, Model 1500, 3000

- Pathway: 510(k) (Traditional)
- Applicant: Lucid, Inc.
- Decided: Sep 17, 2008 after 181 days
- Product code: PSN (Light Based Imaging)
- Device class: 2
- Regulation: 21 CFR 878.4580
- 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 K023729 (2003). 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)
- K023729: Siascope II, Astron Clinica Limited (2003) Summary page 4.

## Cited in the summary but kept off the family tree
- K040171: Microderm, Model/Version 3.5, Visiomed AG (2004). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The VivaScope® System is intended to acquire, store, retrieve, display and transfer in vivo images of tissue, including blood, collagen and pigment, in exposed unstained epithelium and the supporting stroma for review by physicians to assist in forming a clinical judgment.

Source page: https://510kreport.com/device/K080788
Methodology: https://510kreport.com/methodology