FDA.reportPublic FDA data

Fiberoptics Technology Inc

Primary DI
00862658000302
Brand
Fiberoptics Technology Inc
Company
FIBEROPTICS TECHNOLOGY, INC.
Model
LO-50
Device description
LO-50 LED Fiber Optic Light Source
Published
2017-04-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FCWLight Source, Fiberoptic, Routine
NTNLed Light Source

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FCWLight Source, Fiberoptic, RoutineGastroenterology, Urology2
NTNLed Light SourceGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K102167000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K102167000LO-50 LED LIGHT SOURCEFiberoptics Technology, Inc.2010-08-17NTN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00862658000302PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00862658000302008626580003028626580003020862658000302

GMDN Terms#

Term, Definition table
TermDefinition
Operating lightA device designed to provide a specialized source of light for illumination of a site of medical intervention. It provides a high intensity, high colour rendering field of light that minimizes shadows and the emission of heat. It typically consists of an individual light head with more than one light source which may include halogen bulbs or light-emitting diodes (LEDs), reflectors, mirrors and a mechanism to adjust the focus. This device is usually mounted to the ceiling or wall of an operating room (OR) and the mount may be included. It can be part of an OR light system comprising more than one light head.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
088324827
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00862658000333Fiberoptics Technology INCFTIMG 3.5mm2023-01-25
00862658000340Fiberoptics Technology INCFTIMG 5mm2023-01-25
00862658000326Fiberoptics Technology IncFTIHL2021-07-26
00862658000319Fiberoptics Technology IncFiber Optic Medical Light Guide2017-04-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817325025003iVisionMEDIMAX TECH INC.NTN2026-04-30
04250480104262N/ASCHÖLLY FIBEROPTIC GmbHFCW2025-06-11
04547410513790FUJIFILMFUJIFILM CORPORATIONNTN2025-05-31
04953170458170OTV-S500 UPGRADE PACK STROBEOLYMPUS MEDICAL SYSTEMS CORP.NTN2025-03-17
04953170458231AIR MICROPHONEOLYMPUS MEDICAL SYSTEMS CORP.NTN2025-03-17
04953170458248MICROPHONE EXTENSION CABLEOLYMPUS MEDICAL SYSTEMS CORP.NTN2025-03-17
04953170458255HDMI CABLEOLYMPUS MEDICAL SYSTEMS CORP.NTN2025-03-17
04953170458354THROAT MICROPHONEOLYMPUS MEDICAL SYSTEMS CORP.NTN2025-03-17
00810024670260Dragonfly Pancreaticobiliary Scope and Instrument Channel CapsCENTERPOINT SYSTEMS LLCNTN2024-07-22
04250480113530N/ASCHÖLLY FIBEROPTIC GmbHNTN2024-01-08
04250480113677EleVision™SCHÖLLY FIBEROPTIC GmbHNTN2024-01-08
04250480109045N/ASCHÖLLY FIBEROPTIC GmbHFCW2023-10-24
08033638801048Pen LEDSAPI MED SPANTN2023-08-02
06973786290078lmaging Processor System (lncluding Light Source)Shanghai SeeGen Photoelectric Technology Co.,Ltd. (YinDu Road Factory)NTN2023-07-26
04953170414596EVIS X1 VIDEO SYSTEM CENTEROLYMPUS MEDICAL SYSTEMS CORP.NTN2023-07-04
0495317041560912G-SDI cable 1.5MOLYMPUS MEDICAL SYSTEMS CORP.NTN2023-07-04
0495317041562312G-SDI cableOLYMPUS MEDICAL SYSTEMS CORP.NTN2023-07-04
0495317041563012G-SDI cable 8.5MOLYMPUS MEDICAL SYSTEMS CORP.NTN2023-07-04
049531704156473G-SDI cable 1.5MOLYMPUS MEDICAL SYSTEMS CORP.NTN2023-07-04
04953170415654Foot holderOLYMPUS MEDICAL SYSTEMS CORP.NTN2023-07-04
04953170415685Footswitch Conversion cableOLYMPUS MEDICAL SYSTEMS CORP.NTN2023-07-04
04953170420191GASTROINTESTINAL VIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.NTN2023-07-04
04953170424281COLONOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.NTN2023-07-04
04953170424298COLONOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.NTN2023-07-04
20845854050719eLUMAConmed CorporationNTN2020-07-21
04547410384543FUJIFILMFUJIFILM CORPORATIONNTN2020-07-20
04547410420685FUJIFILMFUJIFILM CORPORATIONNTN2020-03-15
04953170391408Power cordOLYMPUS MEDICAL SYSTEMS CORP.NTN2019-09-12
03760278260342COMEG MEDICAL TECHNOLOGIESSOPROFCW2019-07-16
03760278260861COMEG MEDICAL TECHNOLOGIESSOPROFCW2019-07-16