FDA device listing
DPRO,EnDoucer Dermolissage,Silk Peel Dermalinfusion,SilkPeel MD,SilkPeel Pro,SilkPeel Spa,SP3
FDA device listing 1941139326 · ZELTIQ Aesthetics, Inc.
Key facts
| Proprietary names | DPRO,EnDoucer Dermolissage,Silk Peel Dermalinfusion,SilkPeel MD,SilkPeel Pro,SilkPeel Spa,SP3 |
|---|---|
| Owner/operator | ZELTIQ Aesthetics, Inc. |
| Owner/operator number | 10025698 |
| Product codes | GFE |
| Device names | GFE - Brush, Dermabrasion, Powered |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4820 |
| Review panels | General & Plastic Surgery |
| Registered establishments | Zeltiq Aesthetics Inc, ZELTIQ AESTHETICS INC., ZELTIQ AESTHETICS, INC. |
| Establishment registrations | 3007215625, 3009974688, 3011837770, 3014214244 |
| FEI numbers | 3007215625, 3009974688, 3011837770, 3014214244 |
| Establishment operations | Manufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed 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