FDA Registration
Active
🇺🇸 United States
AZENA MEDICAL
Reg #: 3011877721
·
FEI: 3011877721
·
Expires 2026
Products
3
Proprietary Names
4
Establishment Types
2
Classifications
3
Registration Details
- Registration Name
- AZENA MEDICAL
- Registration Number
- 3011877721
- FEI Number
- 3011877721
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1777 Botelho Dr Ste 100
- City
- Walnut Creek
- State
- CA
- ZIP
- 94596
- Country
- US
Regulatory Submissions
- 510(k) Number
- K152032
Owner / Operator
- Firm Name
- Azena Medical
- Operator Number
- 10051175
- Address
- 1777 Bothelo Dr. Suite 100
- City
- Walnut Creek
- State
- CA
- Postal Code
- 94596
- Country
- US
- Correspondent
- Lindsay Tilton
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2016-02-11 |
| Laser, Dental, Soft Tissue | NVK | Class 2 | General, Plastic Surgery | No | 2026-03-26 |
| Lamp, Infrared, Therapeutic Heating | ILY | Class 2 | Physical Medicine | No | 2026-03-26 |
Proprietary Names
Gemini 810+980 Soft Tissue Laser
Gemini NOVA
Gemini EVO
Gemini Diode Laser
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device