OKJ
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Light Based Treatment For Cold Sores Herpes Simplex Virus-1
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4860
- Medical specialty
- General, Plastic Surgery
- FDA 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Luminance Red Cold Sore Device (TN1927G) (K251973) | Luminance Medical Ventures, Inc. | 2025-09-23 |
| Cold Sore Device (QPZ-03) (K241155) | Shenzhen Nuon Medical Equipment Co., Ltd. | 2024-09-05 |
| Cold Sore Device (Model: QPZ-01) (K222205) | Light Tree Ventures Europe B.V. | 2022-10-07 |
| VIRULITE COLD SORE MACHINE (DEN090012) | Virulite, LLC | 2012-10-18 |
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Every clearance here is in the API, with alerts when new ones post.