OKJ — Light Based Treatment For Cold Sores Herpes Simplex Virus-1 Class II
Classification Details
- Product Code
- OKJ
- Device Class
- Class II
- Regulation Number
- 878.4860
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K251973 | luminance medical ventures | Luminance Red Cold Sore Device (TN1927G) | September 23, 2025 |
| K241155 | shenzhen nuon medical equipment co | Cold Sore Device (QPZ-03) | September 5, 2024 |
| K222205 | light tree ventures europe | Cold Sore Device (Model: QPZ-01) | October 7, 2022 |
| DEN090012 | virulite | VIRULITE COLD SORE MACHINE | October 18, 2012 |