FDA product code OKJ: Light Based Treatment For Cold Sores Herpes Simplex Virus-1
OKJ is the FDA product code for light based treatment for cold sores herpes simplex virus-1. It is a Class II device, regulated under 21 CFR 878.4860 and reviewed by the General and Plastic Surgery panel. FDA has cleared 3 510(k) submissions under OKJ, 3 in the last five years, from 3 different applicants. The average 510(k) review took 99 days (median 89); 111 days on average over the last three years. 1 De Novo request was granted under it.
Definition
Shortens time to healing of herpes simplex lesions on the lips, with time to healing defined as the time to patient described re-epithelialization.
Classification
| Field | Value |
|---|---|
| Device name | Light Based Treatment For Cold Sores Herpes Simplex Virus-1 |
| Device class | Class II |
| Regulation | 21 CFR 878.4860 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
510(k) clearances per year for OKJ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2022 | 1 | 74 |
| 2024 | 1 | 133 |
| 2025 | 1 | 89 |
Compare with all 510(k) review times · Search every OKJ clearance
Top OKJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Luminance Medical Ventures, Inc. | 1 | 2025-09-23 |
| Shenzhen Nuon Medical Equipment Co., Ltd. | 1 | 2024-09-05 |
| Light Tree Ventures Europe B.V. | 1 | 2022-10-07 |
Most recent OKJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K251973 | Luminance Medical Ventures, Inc. | Luminance Red Cold Sore Device (TN1927G) | 2025-09-23 | 89 |
| K241155 | Shenzhen Nuon Medical Equipment Co., Ltd. | Cold Sore Device (QPZ-03) | 2024-09-05 | 133 |
| K222205 | Light Tree Ventures Europe B.V. | Cold Sore Device (Model: QPZ-01) | 2022-10-07 | 74 |
Recalls for OKJ devices
openFDA lists no recalls for product code OKJ.
Frequently asked questions
What is FDA product code OKJ?
OKJ is the FDA product code for light based treatment for cold sores herpes simplex virus-1. It is a Class II device, regulated under 21 CFR 878.4860 and reviewed by the General and Plastic Surgery panel.
What device class is OKJ?
Class II, regulation 21 CFR 878.4860. Typical premarket route: 510(k).
How long does a 510(k) take for product code OKJ?
Across 3 cleared submissions the average was 99 days from receipt to decision (median 89).
Which companies have the most OKJ clearances?
Luminance Medical Ventures, Inc. (1); Shenzhen Nuon Medical Equipment Co., Ltd. (1); Light Tree Ventures Europe B.V. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OKJ
- Run a recall and safety report across every OKJ manufacturer
- Watch product code OKJ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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