FDA Registration
Active
🇺🇸 United States
SUNOPTIC TECHNOLOGIES, LLC
Reg #: 1035968
·
FEI: 1035968
·
Expires 2026
Products
17
Proprietary Names
19
Establishment Types
2
Classifications
17
Registration Details
- Registration Name
- SUNOPTIC TECHNOLOGIES, LLC
- Registration Number
- 1035968
- FEI Number
- 1035968
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 6018 BOWDENDALE AVE.
- City
- JACKSONVILLE
- State
- FL
- ZIP
- 32216
- Country
- US
Regulatory Submissions
- 510(k) Number
- K961074
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, Surgical, Floor Standing | FSS | Class 2 | General, Plastic Surgery | No | 2003-04-21 |
| Light, Surgical, Fiberoptic | FST | Class 2 | General, Plastic Surgery | No | 2003-04-21 |
| Camera, Surgical And Accessories | KQM | Class 1 | General, Plastic Surgery | No | 2020-06-19 |
| Light, Surgical, Carrier | FSZ | Class 2 | General, Plastic Surgery | No | 2021-09-08 |
| Light, Surgical Headlight | EBA | Class 1 | Dental | No | 2007-09-12 |
| 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 |
| Light Source, Photographic, Fiberoptic | FCR | Class 2 | Gastroenterology, Urology | No | 1992-07-08 |
| Laparoscope, Gynecologic (And Accessories) | HET | Class 2 | Obstetrics/Gynecology | No | 1992-07-08 |
| Lamp, Operating-Room | FQP | Class 2 | General, Plastic Surgery | No | 2020-03-24 |
| Headlamp, Operating, Battery-Operated | HPP | Class 1 | Ophthalmic | No | 2011-06-21 |
| Source, Carrier, Fiberoptic Light | EQH | Class 1 | Ear, Nose, Throat | No | 1992-07-08 |
| Light, Surgical, Endoscopic | FSW | Class 2 | General, Plastic Surgery | No | 2003-04-21 |
| Camera, Television, Endoscopic, Without Audio | FWF | Class 1 | General, Plastic Surgery | No | 2006-05-18 |
| Accessories, Arthroscopic | NBH | Class 1 | Orthopedic | No | 2023-04-05 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2021-09-08 |
Proprietary Names
Light Source
LIGHT, SURGICAL, FIBEROPTIC
Sunoptic Surgical
TracLux Light Carrier
Customer brand
Sunoptics Surgical
BRAND
Cuda
FIBEROPTIC HEADLIGHT SYSTEM
Customer Brand
ILLUMINATOR
FOR ENDOSCOPE
FIBEROPTIC
Lamp, operating-room
LED HEADLAMP WITH BATTERY-PACK
DPLS-01, Xenon Lightsource
Fiberoptic Cable
Light source, fiberoptic, routine
TracLux HandLite
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)