FDA device listing
Rystora® Silicone Scar Gel
FDA device listing 1408289767 · FORTUNE MEDICAL INSTRUMENT CORP.
Key facts
| Proprietary names | Rystora® Silicone Scar Gel |
|---|---|
| Owner/operator | FORTUNE MEDICAL INSTRUMENT CORP. |
| Owner/operator number | 8022978 |
| Product codes | PFP |
| Device names | PFP - Silicone Hydrogel For Scar Management |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4025 |
| Review panels | General & Plastic Surgery |
| Registered establishments | FORTUNE MEDICAL INSTRUMENT CORP. |
| Establishment registrations | 8022978 |
| FEI numbers | 3006582718 |
| Establishment operations | Manufacturer |
| 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