FDA device listing
Fraxel re:store DUAL Laser System
FDA device listing 1959857667 · Solta Medical
Key facts
| Proprietary names | Fraxel re:store DUAL Laser System |
|---|---|
| Owner/operator | Solta Medical |
| Owner/operator number | 9042311 |
| Premarket submissions | K101490 |
| Product codes | ONG |
| Device names | ONG - Powered Laser Surgical Instrument With Microbeam\Fractional Output |
| Device class | Class II |
| Classification regulations (21 CFR) | 878.4810 |
| Review panels | General & Plastic Surgery |
| Registered establishments | Solta Medical, Inc. |
| Establishment registrations | 3011423170 |
| FEI numbers | 3004106598 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 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