FDA device listing
ML830 Smart Laser
FDA device listing 1817171805 · ITI Manufacturing Inc.
Key facts
| Proprietary names | ML830 Smart Laser |
|---|---|
| Owner/operator | ITI Manufacturing Inc. |
| Owner/operator number | 10031312 |
| Product codes | NHN |
| Device names | NHN - Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy |
| Device class | Class II |
| Classification regulations (21 CFR) | 890.5500 |
| Review panels | Physical Medicine |
| Registered establishments | ITI Manufacturing Inc. |
| Establishment registrations | 3000985188 |
| FEI numbers | 3000985188 |
| Establishment operations | Contract 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