De Novo · Granted
GrantedVirulite Cold Sore Machine
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Virulite, LLC · OKJ Light Based Treatment For Cold Sores Herpes Simplex Virus-1
Granted on Oct 18, 2012 as a new device type through De Novo after a 1,206-day review. 3 later devices descend from it.
- Decided
- Oct 18, 2012
- Review
- 1,206 days
- Class
- Class II
- Product code
- OKJ
- Recalls
- None
3 later devices descend from it, 1 citing it directly.
- This deviceDEN090012 Virulite Cold Sore MachineVirulite, LLC · 2012
- Descendant · cites it directly · 2 of its ownK222205 Cold Sore Device (Model: QPZ-01)Light Tree Ventures Europe B.V. · 2022
- Descendant · 2 generations on · 0 of its ownK251973 Luminance Red Cold Sore Device (TN1927G)Luminance Medical Ventures, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK241155 Cold Sore Device (QPZ-03)Shenzhen Nuon Medical Equipment Co., Ltd. · 2024
Most influential descendants
Showing 3 of 3 · See all- K222205Cold Sore Device (Model: QPZ-01)Light Tree Ventures Europe B.V. · 2022 · cites it directly2descendants
- K251973Luminance Red Cold Sore Device (TN1927G)Luminance Medical Ventures, Inc. · 2025 · 2 generations on0descendants
- K241155Cold Sore Device (QPZ-03)Shenzhen Nuon Medical Equipment Co., Ltd. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN090012 | Virulite Cold Sore Machine | Virulite, LLC | 2012 | — |
| +1 | K222205 | Cold Sore Device (Model: QPZ-01) | Light Tree Ventures Europe B.V. | 2022 | — |
| +2 | K251973 | Luminance Red Cold Sore Device (TN1927G) | Luminance Medical Ventures, Inc. | 2025 | — |
| +2 | K241155 | Cold Sore Device (QPZ-03) | Shenzhen Nuon Medical Equipment Co., Ltd. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA De Novo 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 OKJ? 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 OKJ device
- #1 K251973 Luminance Red Cold Sore Device (TN1927G)score 10.4 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K222205 | Cold Sore Device (Model: QPZ-01) | 2022 | 2 |
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?
- Of its descendants, K222205 (Light Tree Ventures Europe B.V., 2022) has gone furthest, with 2 descendants of its own.
How does its category compare?
All OKJ devicesOKJ Light Based Treatment For Cold Sores Herpes Simplex Virus-1: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · OKJ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OKJ
Too few OKJ 510(k)s in any year since 2007 to give a median.
Recalls per year · OKJ
No recall names OKJ since 2007.
Adverse event reports per year · OKJ
1in 2019
MAUDE reports naming product code OKJ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The ViruLite Cold Sore Machine is indicated for shortening the time to healing of herpes simplex labialis lesions on or around the lips with time to healing defined as the time to patient described re-epithelialization.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN090012 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN090012: Virulite Cold Sore Machine.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN090012
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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