FDA device listing
KELO-COTE; ScarAway Silicone Scar Gel
FDA device listing 1363002469 · Formulated Solutions, LLC
Key facts
| Proprietary names | KELO-COTE; ScarAway Silicone Scar Gel |
|---|---|
| Owner/operator | Formulated Solutions, LLC |
| Owner/operator number | 10033613 |
| Product codes | MDA |
| Device names | MDA - Elastomer, Silicone, For Scar Management |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4025 |
| Review panels | General & Plastic Surgery |
| Registered establishments | FORMULATED SOLUTIONS, LLC |
| Establishment registrations | 3005779557 |
| FEI numbers | 3005779557 |
| Establishment operations | Contract 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