Product code
OAP: Laser, comb, hair
FDA product code · Class II · General & Plastic Surgery
Key facts
| Product code | OAP |
|---|---|
| Device | Laser, comb, hair |
| Device class | Class II |
| Regulation number | 890.5500 |
| 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 | Promote hair growth in males with androgenic alopecia and norwood hamilton classification of iia to v |
At a glance
- 100–999 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 100–999 UDI devices (GUDID)
- 10–99 MAUDE adverse event reports
- 1–9 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