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Data / Medical devices / United States / Fiberoptics Technology, Inc.

Fiberoptics Technology, Inc.: FDA-registered device maker in Pomfret, CT, United States, 1 510(k) clearance

Fiberoptics Technology, Inc. is registered with the FDA (registration 1222275) in Pomfret, CT, United States. It lists 6 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 17, 2010. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
1222275
FEI number
1000121058
Address
1 Quassett RD., Pomfret, CT, United States, 06258
Owner or operator
FIBEROPTICS TECHNOLOGY, INC. (9000958)
Roles
Contract manufacturer, Manufacturer, Repackager or relabeler
First device listed
August 11, 1992
Registered through
2026
Brand names listed
E.T.I. MEDICAL LIGHT GUIDE, F.T.I. MEDICAL LIGHT GUIDE, FC1B Bifurcated Fiber Optic Cable 11.5ft, FC1S Single Fiber Optic Cable 10ft, FC1SP Single Fiber Optic Cable 10ft, Pink, Fiber Optic Light Source, Fiberoptics Technology Inc. Surgical Headlight, LED Series LS and more

Devices it lists

DeviceProduct codeClassRoleSource
Headlight, Fiberoptic FocusingFCT2Manufactureraccessdata.fda.gov
Led Light SourceNTN2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Light Source, Fiberoptic, RoutineFCW2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Light, Surgical, FiberopticFST2Contract manufactureraccessdata.fda.gov
Source, Carrier, Fiberoptic LightEQH1Contract manufacturer, Manufactureraccessdata.fda.gov
Stimulator, NerveETN2Contract manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
August 17, 2010K102167LO-50 LED LIGHT SOURCENTNSubstantially EquivalentFiberoptics Technology, Inc.accessdata.fda.gov

Compare with other makers

Updated August 17, 2010. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.