FDA device listing
Perlane,Perlane-L,Restylane,Restylane and Perlane,Restylane and Perlane Injectable Gel,Restylane and Perlane Injectable…
FDA device listing 1581719569 · 3D Medical Technologies Inc.
Key facts
| Proprietary names | Perlane,Perlane-L,Restylane,Restylane and Perlane,Restylane and Perlane Injectable Gel,Restylane and Perlane Injectable Gels,Restylane Eyelight,Restylane Family of Injectable Gels,Restylane Injectable Gel,Restylane Injectable Gels,Restylane-L,Restylane Lyft with Lidocaine Cannula Injection,Restylane Lyft with Lidocane,Restylane Nasha,Restylane Silk,Restylane Silk Injectable Gels,Restylane Silk… |
|---|---|
| Owner/operator | 3D Medical Technologies Inc. |
| Owner/operator number | 10095560 |
| Premarket submissions | P040024 |
| Product codes | LMH, PKY |
| Device names | LMH - Implant, Dermal, For Aesthetic Use, PKY - Implant, Dermal, For Aesthetic Use In The Hands |
| Device class | Class III |
| Classification regulations (21 CFR) | ORCA1.LMH, ORCA1.PKY |
| 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
- 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