510(k) · Cleared
ClearedCold Sore Device (Model: QPZ-01)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Light Tree Ventures Europe B.V. · OKJ Light Based Treatment For Cold Sores Herpes Simplex Virus-1
Cleared on Oct 7, 2022 as substantially equivalent to DEN090012 (Virulite, LLC, 2012) and 1 other predicate after a 74-day review. Its family tree reaches back 1 generation to 2012. 2 later devices descend from it.
- Decided
- Oct 7, 2022
- Review
- 74 days
- Class
- Class II
- Product code
- OKJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to DEN090012 (2012). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backDEN090012 Virulite Cold Sore MachineVirulite, LLC · 2012
- This deviceK222205 Cold Sore Device (Model: QPZ-01)Light Tree Ventures Europe B.V. · 2022
- Descendant · cites it directly · 0 of its ownK251973 Luminance Red Cold Sore Device (TN1927G)Luminance Medical Ventures, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK241155 Cold Sore Device (QPZ-03)Shenzhen Nuon Medical Equipment Co., Ltd. · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN090012 | Virulite Cold Sore Machine | Virulite, LLC | 2012 | — |
| 0 (this device) | K222205 | Cold Sore Device (Model: QPZ-01) | Light Tree Ventures Europe B.V. | 2022 | — |
| +1 | K251973 | Luminance Red Cold Sore Device (TN1927G) | Luminance Medical Ventures, Inc. | 2025 | — |
| +1 | 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 |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
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 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
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN090012 | Virulite Cold Sore MachineSummary page 4…tion Sponsor: VIRULITE LLC Trade Name: ViruLite Cold Sore Machine (ViruLite) Classification Name: Light based energy source device for topical application 510(K) Number: DEN090012/K083767 Review Panel: General & Plastic Surgery Product Code: OKJ Regulation Number: 21 CFR 878.4860 Regulation Class: II… | 2012 |
| * | DEN090012 | Virulite Cold Sore Machine Our reading of the summary gave K083767, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN090012, Virulite Cold Sore Machine (Virulite, LLC), granted Oct 18, 2012; older De Novo requests were first filed under a 510(k) number, so this links to the grant. | 2012 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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.
- Of its descendants, K251973 (Luminance Medical Ventures, Inc., 2025) has gone furthest, with 0 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. 2022, 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 Cold Sore Device 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K222205 · printed Nov 5, 2026
Cite this page
510(k) Report. “K222205: Cold Sore Device (Model: QPZ-01).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K222205
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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