Product code
OZC: Over the counter thermal treatment for acne.
FDA product code · Class II · General & Plastic Surgery
Key facts
| Product code | OZC |
|---|---|
| Device | Over the counter thermal treatment for acne. |
| Device class | Class II |
| Regulation number | 890.5740 |
| Review panel | General & Plastic Surgery |
| Medical specialty | Physical Medicine |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | For the treatment of mild to moderate inflammatory acne. |
At a glance
- 1–9 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 1–9 UDI devices (GUDID)
- None 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