FDA Registration
Active
🇺🇸 United States
BRAND
Reg #: 1035968
·
FEI: 1035968
·
Expires 2025
Products
5
Proprietary Names
7
Establishment Types
2
Classifications
5
Registration Details
- Registration Name
- SUNOPTIC TECHNOLOGIES, LLC
- Registration Number
- 1035968
- FEI Number
- 1035968
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 6018 BOWDENDALE AVE.
- City
- JACKSONVILLE
- State
- FL
- ZIP
- 32216
- Country
- US
Regulatory Submissions
- 510(k) Number
- K980166
Owner / Operator
- Firm Name
- SUNOPTIC TECHNOLOGIES, LLC
- Operator Number
- 1035968
- Address
- 6018 BOWDENDALE AVE., --
- City
- Jacksonville
- State
- FL
- Postal Code
- 32216
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Light Source, Photographic, Fiberoptic | FCR | Class 2 | Gastroenterology, Urology | No | 1992-07-08 |
| Illuminator, Fiberoptic, Surgical Field | HBI | Class 2 | General, Plastic Surgery | No | 1992-07-08 |
| Light Source, Fiberoptic, Routine | FCW | Class 2 | Gastroenterology, Urology | No | 1992-07-08 |
| Image, Illumination, Fiberoptic, For Endoscope | FFS | Class 2 | Gastroenterology, Urology | No | 1992-07-08 |
| Laparoscope, Gynecologic (And Accessories) | HET | Class 2 | Obstetrics/Gynecology | No | 1992-07-08 |
Proprietary Names
BRAND
Cuda
ILLUMINATOR
FIBEROPTIC
FOR ENDOSCOPE
Customer Brand
Sunoptics Surgical
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device