510(k) · Cleared
ClearedLuminance Red Cold Sore Device (TN1927G)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Luminance Medical Ventures, Inc. · OKJ Light Based Treatment For Cold Sores Herpes Simplex Virus-1
Cleared on Sep 23, 2025 as substantially equivalent to K222205 (Light Tree Ventures Europe B.V., 2022) after an 89-day review. Its family tree reaches back 2 generations to 2012.
- Decided
- Sep 23, 2025
- Review
- 89 days
- Class
- Class II
- Product code
- OKJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN090012 (2012). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 K222205 Cold Sore Device (Model: QPZ-01)score 10.1 · 1 generation · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K222205 | Cold Sore Device (Model: QPZ-01)Summary page 5…21 CFR 807.92(a)(3) Predicate# Predicate Trade Name (Primary Predicate is listed first) Product Code I K222205 11 Light Tree Ventures, Cold Sore Device… | 2022 |
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?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 10.0 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K222205.
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. 2025, 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 Luminance Red Cold Sore device is indicated for shortening the time to healing of herpes simplex labialis lesions on and around the lips with time to healing defined as the time to patient described re-epithelialization.
This device is suitable for users with Fitzpatrick skin types I-IV.
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/K251973 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251973: Luminance Red Cold Sore Device (TN1927G).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251973
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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