FDA device listing
flacara h1,LumoScanner Derm
FDA device listing 1562000203 · Lumo Imaging
Key facts
| Proprietary names | flacara h1,LumoScanner Derm |
|---|---|
| Owner/operator | Lumo Imaging |
| Owner/operator number | 10095476 |
| Product codes | FTT |
| Device names | FTT - Camera, Still, Surgical |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4160 |
| Review panels | General & Plastic Surgery |
| Registered establishments | Lumo Imaging LLC |
| Establishment registrations | 3043725403 |
| FEI numbers | 3043725403 |
| Establishment operations | Complaint File Establishment, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database