FDA Registration
Active
🇺🇸 United States
FIBEROPTICS TECHNOLOGY, INC.
Reg #: 1222275
·
FEI: 1000121058
·
Expires 2026
Products
6
Proprietary Names
11
Establishment Types
3
Classifications
6
Registration Details
- Registration Name
- FIBEROPTICS TECHNOLOGY, INC.
- Registration Number
- 1222275
- FEI Number
- 1000121058
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1 QUASSETT RD.
- City
- Pomfret
- State
- CT
- ZIP
- 06258
- Country
- US
Regulatory Submissions
- 510(k) Number
- K102167
Owner / Operator
- Firm Name
- FIBEROPTICS TECHNOLOGY, INC.
- Operator Number
- 9000958
- Address
- 1 Quassett Rd., --
- City
- Pomfret
- State
- CT
- Postal Code
- 06258
- Country
- US
- Correspondent
- Zachary K Morin
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stimulator, Nerve | ETN | Class 2 | Ear, Nose, Throat | No | 2026-01-14 |
| Source, Carrier, Fiberoptic Light | EQH | Class 1 | Ear, Nose, Throat | No | 1992-08-11 |
| Light, Surgical, Fiberoptic | FST | Class 2 | General, Plastic Surgery | No | 2026-01-14 |
| Led Light Source | NTN | Class 2 | Gastroenterology, Urology | No | 2013-04-19 |
| Light Source, Fiberoptic, Routine | FCW | Class 2 | Gastroenterology, Urology | No | 2013-04-19 |
| Headlight, Fiberoptic Focusing | FCT | Class 2 | Ophthalmic | No | 2021-07-23 |
Proprietary Names
E.T.I. MEDICAL LIGHT GUIDE
F.T.I. MEDICAL LIGHT GUIDE
Xena Light Light Source
Xenon Light Source
LED Series LS
Fiber Optic Light Source
LO-50 Light Source
FC1B Bifurcated Fiber Optic Cable 11.5ft
FC1SP Single Fiber Optic Cable 10ft, Pink
FC1S Single Fiber Optic Cable 10ft
Fiberoptics Technology Inc. Surgical Headlight
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device
Repack or Relabel Medical Device