Product code
OKJ: Light based treatment for cold sores herpes simplex virus-1
FDA product code · Class II · General & Plastic Surgery
Key facts
| Product code | OKJ |
|---|---|
| Device | Light based treatment for cold sores herpes simplex virus-1 |
| Device class | Class II |
| Regulation number | 878.4860 |
| Review panel | General & Plastic Surgery |
| Medical specialty | General & Plastic Surgery |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | 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. |
At a glance
- 1–9 510(k) clearances
- 1–9 De Novo grants
- None PMA approvals
- None HDE approvals
- 1–9 UDI devices (GUDID)
- 1–9 MAUDE adverse event reports
- None Recalled products (Z-numbers)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device product codes
FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.
Source: U.S. Food and Drug Administration (FDA), Product Classification database