FDA device listing
ALU-40LED-CF - LIGHT PORTABLE LED OPERATORY 6520-01-600-8241,ALU-40LED - LIGHT PORTABLE LED OPERATORY,ALU-40MOM - LIGHT…
FDA device listing 1876164172 · ASEPTICO, INC.
Key facts
| Proprietary names | ALU-40LED-CF - LIGHT PORTABLE LED OPERATORY 6520-01-600-8241,ALU-40LED - LIGHT PORTABLE LED OPERATORY,ALU-40MOM - LIGHT PORTABLE LED OPERATORY MOM,ALU-40MOM - LIGHT PORTABLE LED OPERATORY W/STAND MOM |
|---|---|
| Owner/operator | ASEPTICO, INC. |
| Owner/operator number | 3017604 |
| Product codes | EAZ |
| Device names | EAZ - Light, Operating, Dental |
| Device class | Class I |
| Classification regulations (21 CFR) | 872.4630 |
| Review panels | Dental |
| Registered establishments | ASEPTICO, INC. |
| Establishment registrations | 3017604 |
| FEI numbers | 3017604 |
| Establishment operations | Complaint File Establishment, Manufacturer |
| 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