FDA device listing
Radiesse,Radiesse 0.3CC,Radiesse 0.8cc and 1.5CC,Radiesse 1.3CC and 0.3CC,Radiesse 1.5CC,Radiesse 1.5CC and…
FDA device listing 2017986265 · 3D Medical Technologies Inc.
Key facts
| Proprietary names | Radiesse,Radiesse 0.3CC,Radiesse 0.8cc and 1.5CC,Radiesse 1.3CC and 0.3CC,Radiesse 1.5CC,Radiesse 1.5CC and 0.3CC,Radiesse Dermal Filler,Radiesse Implant,Radiesse Injectable Implant,Radiesse Injectable Implant- 0.3C,Radiesse Injectable Implant 0.8CC,Radiesse Injectable Implant 1.5CC,Radiesse Injectable Implant 8069M0,Radiesse Injectable Implant 8071M0,Radiesse Injectable Implant for sub-dermal… |
|---|---|
| Owner/operator | 3D Medical Technologies Inc. |
| Owner/operator number | 10095560 |
| Premarket submissions | P050037 |
| Product codes | LMH |
| Device names | LMH - Implant, Dermal, For Aesthetic Use |
| Device class | Class III |
| Classification regulations (21 CFR) | ORCA1.LMH |
| Review panels | General & Plastic Surgery |
| Registered establishments | 3D MEDICAL TECHNOLOGIES INC. |
| Establishment registrations | 3045078914 |
| FEI numbers | 3045078914 |
| Establishment operations | Foreign Exporter, Foreign Private Label Distributor |
| 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