FDA device listing
Microlight (TM) ML830(R)
FDA device listing 1414854497 · SHENZHEN SHINELONG ELECTRONICS INDUSTRIAL CO.LTD (SEIC)
Key facts
| Proprietary names | Microlight (TM) ML830(R) |
|---|---|
| Owner/operator | SHENZHEN SHINELONG ELECTRONICS INDUSTRIAL CO.LTD (SEIC) |
| Owner/operator number | 9066728 |
| Premarket submissions | K010175 |
| 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 | SEIC SHENZHEN SHINELONG ELECTRONICS INDUSTRIAL CO. |
| Establishment registrations | 3004779467 |
| FEI numbers | 3004779467 |
| Establishment operations | Contract Manufacturer, Foreign Exporter |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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