FDA device listing
1060nm laser body slimming machine
FDA device listing 1431048617 · Hebei JT Medical Co.,Ltd
Key facts
| Proprietary names | 1060nm laser body slimming machine |
|---|---|
| Owner/operator | Hebei JT Medical Co.,Ltd |
| Owner/operator number | 10083488 |
| Premarket submissions | K240658 |
| Product codes | PKT |
| Device names | PKT - Laser For Disruption Of Adipocyte Cells For Aesthetic Use |
| Device class | Class II |
| Classification regulations (21 CFR) | 878.5400 |
| Review panels | General & Plastic Surgery |
| Registered establishments | Hebei JT Medical Co.,Ltd |
| Establishment registrations | 3021315370 |
| FEI numbers | 3021315370 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 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