Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1222275

FEI Number

1000121058

Entity Name

FIBEROPTICS TECHNOLOGY, INC.

City/State/Country

Pomfret, CT, US

Establishment Address

1 QUASSETT RD., Pomfret, CT 06258, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

FIBEROPTICS TECHNOLOGY, INC. (Owner Number: 9000958)

Owner / Operator Contact Address

1 Quassett Rd., --, Pomfret, CT 06258, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2026-01-14
EQH	Source, Carrier, Fiberoptic Light	Ear, Nose, Throat	Class 1	874.4350	1992-08-11
FST	Light, Surgical, Fiberoptic	General, Plastic Surgery	Class 2	878.4580	2026-01-14
NTN	Led Light Source	Gastroenterology, Urology	Class 2	876.1500	2013-04-19
FCW	Light Source, Fiberoptic, Routine	Gastroenterology, Urology	Class 2	876.1500	2013-04-19
FST	Light, Surgical, Fiberoptic	General, Plastic Surgery	Class 2	878.4580	2026-05-22

Official Correspondent

Zachary Morin

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

FIBEROPTICS TECHNOLOGY, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K833646	Edward Weck, Inc.	PULSATRON NERVE LOCATOR/STIMULATOR	1984-02-10
K150005	Ndi Medical, LLC	Checkpoint, Checkpoint Head & Neck	2015-02-19
K901491	Cuda Products Co.	CUDA SURGICAL LIGHT	1990-06-18

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0023-2020	Stryker Instruments Div. of Stryker Corporation	2	C2 Nerve Monitor, 4 Channel, 5140-508-240, UDI 07613327177329 Product Usage: The C2 Nerve Monitor System is intended for intra-operative monitoring and stimulation for localization and identification of cranial and peripheral motor and mixed motor sensory nerves during surgery.
Z-0024-2020	Stryker Instruments Div. of Stryker Corporation	2	C2 Nerve Monitor, 8 Channel, 5140-508-280, UDI 07613327277319 Product Usage: The C2 Nerve Monitor System is intended for intra-operative monitoring and stimulation for localization and identification of cranial and peripheral motor and mixed motor sensory nerves during surgery.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1222275. Last updated year: 2026. Please use registration number 1222275 when referencing this establishment in official correspondence.