510(k) · Cleared
ClearedVivascope System, Model 1500, 3000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lucid, Inc. · PSN Light Based Imaging
Cleared on Sep 17, 2008 as substantially equivalent to K023729 (Astron Clinica Limited, 2003) after a 181-day review. Its family tree reaches back 1 generation to 2003.
- Decided
- Sep 17, 2008
- Review
- 181 days
- Class
- Class II
- Product code
- PSN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K023729 (2003). No later device cites it as a predicate yet.
- Root · 1 generation backK023729 Siascope IIAstron Clinica Limited · 2003
- This deviceK080788 Vivascope System, Model 1500, 3000Lucid, Inc. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K023729 | Siascope II | Astron Clinica Limited | 2003 | — |
| 0 (this device) | K080788 | Vivascope System, Model 1500, 3000 | Lucid, Inc. | 2008 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PSN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new PSN device
- #1 K230448 DeepX DermoSight Dermatoscopescore 6.2 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K040171 | FDA’s K040171 is Microderm, Model/Version 3.5 Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2004 |
| * | K023729 | Siascope IISummary page 4…ct Codes of Equivalent Devices MicroDERM® 510(k) Number: K(40171 Product Code: FSS CFR Section: 878.4580 Visiomed AG, Ft. Lauderdale, FL SiaScope Il 510(k) Number: K023729 Product Code: FSS CFR Scction: 878.4580 Astron Clinica, Ltd., Crofton, MD Section 5 Page 1 of 3 Intended Usc… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K023729.
How does its category compare?
All PSN devicesPSN Light Based Imaging: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · PSN
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · PSN
Too few PSN 510(k)s in any year since 2007 to give a median.
Recalls per year · PSN
No recall names PSN since 2007.
Adverse event reports per year · PSN
No MAUDE report names PSN since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K080788 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080788: Vivascope System, Model 1500, 3000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080788
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026