FDA device listing
CANDELA FAMILY OF PULSED DYE LASER SYSTEMS, MODELS VBEAM, CBEAM, SPTL-1B
FDA device listing 1449152067 · PIONEER OPTICS CO.
Key facts
| Proprietary names | CANDELA FAMILY OF PULSED DYE LASER SYSTEMS, MODELS VBEAM, CBEAM, SPTL-1B |
|---|---|
| Owner/operator | PIONEER OPTICS CO. |
| Owner/operator number | 9035401 |
| Product codes | GEX |
| Device names | GEX - Powered Laser Surgical Instrument |
| Device class | Class II |
| Classification regulations (21 CFR) | 878.4810 |
| Review panels | General & Plastic Surgery |
| Registered establishments | PIONEER OPTICS CO. |
| Establishment registrations | 1226005 |
| FEI numbers | 1000623228 |
| 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