FDA device listing
Smart Triad 3LT shoulder
FDA device listing 1146231301 · Shenzhen Rainbow Light Medical Equipment Co., Ltd
Key facts
| Proprietary names | Smart Triad 3LT shoulder |
|---|---|
| Owner/operator | Shenzhen Rainbow Light Medical Equipment Co., Ltd |
| Owner/operator number | 10096209 |
| Premarket submissions | K223893 |
| Product codes | OHS |
| Device names | OHS - Light Based Over The Counter Wrinkle Reduction |
| Device class | Class II |
| Classification regulations (21 CFR) | 878.4810 |
| Review panels | General & Plastic Surgery |
| Registered establishments | SHENZHEN RAINBOW LIGHT MEDICAL EQUIPMENT CO., LTD |
| Establishment operations | Foreign Exporter |
| Registration valid through | 2026 |
At a glance
- None Registered establishments listing this device
- None 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