FDA device listing
Sculptra,Sculptra Aesthetic
FDA device listing 2013729150 · Galderma Laboratories, L.P.
Key facts
| Proprietary names | Sculptra,Sculptra Aesthetic |
|---|---|
| Owner/operator | Galderma Laboratories, L.P. |
| Owner/operator number | 10047852 |
| Premarket submissions | P030050 |
| 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 | GALDERMA LABORATORIES, L.P. |
| Establishment registrations | 1000118068 |
| FEI numbers | 1000118068 |
| Establishment operations | Complaint File Establishment |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 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