FDA device listing
Advanced Scar & Wound Hydrogel,Aquanil AD Recovery Gel,Microcyn Scar Management Hydrogel
FDA device listing 1086907431 · Sonoma Pharmaceuticals Inc.
Key facts
| Proprietary names | Advanced Scar & Wound Hydrogel,Aquanil AD Recovery Gel,Microcyn Scar Management Hydrogel |
|---|---|
| Owner/operator | Sonoma Pharmaceuticals Inc. |
| Owner/operator number | 9063175 |
| Premarket submissions | K131672 |
| 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 | Oculus Technologies of Mexico, S.A de C.V., Sonoma Pharmaceuticals, Inc. |
| Establishment registrations | 3004554409, 3007244484 |
| FEI numbers | 3004554409, 3007244484 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None UDI devices (GUDID) under the same submission
- 1–9 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