FDA device listing
Restylane Contour,Restylane Defyne,Restylane Kysse,Restylane Refyne
FDA device listing 1586954119 · Orion Medical Solutions
Key facts
| Proprietary names | Restylane Contour,Restylane Defyne,Restylane Kysse,Restylane Refyne |
|---|---|
| Owner/operator | Orion Medical Solutions |
| Owner/operator number | 10093083 |
| Premarket submissions | P140029 |
| 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 | ORION MEDICAL SOLUTIONS |
| Establishment registrations | 3037006441 |
| FEI numbers | 3037006441 |
| Establishment operations | Complaint File Establishment |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 UDI devices (GUDID) under the same submission
- 10–99 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