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Sign in to claim this brandAzena Medical, LLC
US
Last updated May 31, 2026
What Azena Medical, LLC makes
Azena Medical, LLC makes dental diode laser systems, including the Gemini EVO and Gemini 810+980 Diode Laser models.
These devices are classified as Class II medical devices and are listed in the FDA 510(k) and FDA UDI registries; the company is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- azenamedical.com
- —
- —
- [email protected]
- Phone
- 800-466-5273
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 073483242
Catalogue (17)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Gemini 810+980 Diode Laser Kit, International | 8990 | FDA UDI | Class II | Unknown |
| Gemini EVO | 9120 | FDA UDI | Class II | Active |
| Gemini EVO | 9124 | FDA UDI | Class II | Active |
| Gemini EVO | 9121 | FDA UDI | Class II | Active |
| Gemini 810+980 Diode Laser | EL-5-001 | FDA UDI | Class II | Active |
| Gemini | 8984 | FDA UDI | Class II | Active |
| Gemini | 8985 | FDA UDI | Class II | Active |
| Gemini EVO | 9126 | FDA UDI | Class II | Active |
| Gemini Evo | 9127 | FDA UDI | Class II | Active |
| Gemini EVO | 9122 | FDA UDI | Class II | Active |
| Gemini | 8983 | FDA UDI | Class II | Active |
| Gemini EVO | 9125 | FDA UDI | Class II | Active |
| Gemini EVO | 9123 | FDA UDI | Class II | Active |
| Gemini 810+980 Soft Tissue Laser | K192617 | FDA 510(k) | Class II | Active |
| Gemini 2 810+980 Soft Tissue Laser | K210350 | FDA 510(k) | Class II | Active |
| Gemini NOVA 810+980 Soft Tissue Laser | K260765 | FDA 510(k) | Class II | Active |
| ELUMI 810 + 980 Soft Tissue Laser | K152032 | FDA 510(k) | Class II | Active |
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