OKJ
- Product code
- OKJ
- Device name
- Light Based Treatment For Cold Sores Herpes Simplex Virus-1
- Device class
- Class 2
- 21 CFR
- 21 CFR 878.4860
- Medical specialty
- General, Plastic Surgery
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 4
FDA classification 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.
510(k) clearances, last 3 years (2)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K251973 | 2025-09-23 | Luminance Medical Ventures, Inc. | Luminance Red Cold Sore Device (TN1927G) | FDA |
| K241155 | 2024-09-05 | Shenzhen Nuon Medical Equipment Co., L | Cold Sore Device (QPZ-03) |
Official FDA classification page: OKJ
Classification and pathway per current FDA publications. Data from openFDA (CC0).