510(k) · Cleared
ClearedCold Sore Device (QPZ-03)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Nuon Medical Equipment Co., Ltd. · OKJ Light Based Treatment For Cold Sores Herpes Simplex Virus-1
Cleared on Sep 5, 2024 as substantially equivalent to K222205 (Light Tree Ventures Europe B.V., 2022) after a 133-day review. Its family tree reaches back 2 generations to 2012.
- Decided
- Sep 5, 2024
- Review
- 133 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 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? (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…FR 878.4860 Regulatory Class: II 3. Predicate Device Information Sponsor: Light Tree Ventures Europe B.V. Trade Name: Cold Sore Device Model Name: QPZ-01 510(K) Number: K222205 Review Panel: General & Plastic Surgery Product Code: OKJ Regulation Number: 21 CFR 878.4860 Classification Name: Light based ene… | 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 12 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. 2024, 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 as stated in the FDA summary.
https://510kreport.com/device/K241155 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241155: Cold Sore Device (QPZ-03).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241155
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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