FDA Product Code
FDA Product Code OKJ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4860
510(k) Clearances — 4 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K251973 | Luminance Red Cold Sore Device (TN1927G) | Luminance Medical Ventures, Inc. | 2025-09-23 | Traditional | PDF ↗ |
| K241155 | Cold Sore Device (QPZ-03) | Shenzhen Nuon Medical Equipment Co., Ltd. | 2024-09-05 | Traditional | PDF ↗ |
| K222205 | Cold Sore Device (Model: QPZ-01) | Light Tree Ventures Europe B.V. | 2022-10-07 | Traditional | PDF ↗ |
| DEN090012 | VIRULITE COLD SORE MACHINE | Virulite, LLC | 2012-10-18 | Post-NSE | — |
Product code OKJ · Class II · General, Plastic Surgery. Data: openFDA.