FDA device listing
Rejuva Fresh DermaLaze Delicate Portable - ELight Intense Pulsed Light System DermaLaze,Rejuva Fresh DermaLaze Delicate…
FDA device listing 1912419378 · Rejuva Fresh LLC
Key facts
| Proprietary names | Rejuva Fresh DermaLaze Delicate Portable - ELight Intense Pulsed Light System DermaLaze,Rejuva Fresh DermaLaze Delicate Pro 3 in 1 - ELight Intense Pulsed Light System DermaLaze,Rejuva Fresh DermaLaze Delicate Spectrum - ELight Intense Pulsed Light System DermaLaze |
|---|---|
| Owner/operator | Rejuva Fresh LLC |
| Owner/operator number | 10091638 |
| Premarket submissions | K161286 |
| Product codes | ONF |
| Device names | ONF - Powered Light Based Non-Laser Surgical Instrument With Thermal Effect |
| Device class | Class II |
| Classification regulations (21 CFR) | 878.4810 |
| Review panels | General & Plastic Surgery |
| Registered establishments | REJUVA FRESH LLC |
| Establishment registrations | 3033844600 |
| FEI numbers | 3033844600 |
| Establishment operations | Foreign Exporter |
| 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