FDA.reportPublic FDA data

VISERA ELITE II XENON LIGHT SOURCE

Primary DI
04953170386138
Brand
VISERA ELITE II XENON LIGHT SOURCE
Company
OLYMPUS MEDICAL SYSTEMS CORP.
Model
OLYMPUS CLV-S200-IR
Published
2021-02-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NWBEndoscope, accessories, narrow band spectrum
OWNConfocal optical imaging

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NWBEndoscope, Accessories, Narrow Band SpectrumGastroenterology, Urology2
OWNConfocal Optical ImagingGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200542000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200542000Visera Elite II Xenon Light Source, Telescope IR/Telescope Ultra, Visera Elite II Video System Center, HD 3CMOS Autoclavable Camera Head, HD 3CMOS Camera HeadOlympus Medical Systems Corp.2020-07-17OWN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04953170386138PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04953170386138049531703861384953170386138

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic light source, line-poweredA mains electricity (AC-powered), typically bench-top unit designed to produce light of high intensity, often called cold light, for viewing surgical fields and body cavities when using rigid or flexible endoscopes (e.g., arthroscopes, cystoscopes, laparoscopes, gastroscopes). It provides a source of bright light [e.g., using a xenon (Xe) light bulb] that is channelled to the endoscope via a light cable to illuminate the site of observation/intervention while minimizing tissue heating.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)401-1086xx@xx.xx

Regulatory Flags#

DUNS number
711789789
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04953170025693P CORDMAJ-348125002016-09-21
04953170048548A CORDMH-9692016-09-21
04953170062872A CORDMAJ-8602016-09-21
04953170373763ENDOCAPSULE SOFTWARE 10MAJ-2188N54003402016-09-21
04953170373800ENDOCAPSULE SOFTWARE 10 LIGHTMAJ-2189N54004402016-09-21
04953170373848ENDOCAPSULE SOFTWARE 10 UPGRADE PACKAGEMAJ-2190N54005402016-09-21
04953170360817ENDOCAPSULE SOFTWARE 10 SOFT SERVER-CLIENTMAJ-2038N53688402023-06-21
04953170360824ENDOCAPSULE SOFTWARE 10 SOFTWARE CLIENTMAJ-2039N53689402023-06-21
04953170410178EVIS EUS ULTRASOUND GASTROINTESTINAL VIDEOSCOPEOLYMPUS GF-UE190N60031402025-11-19
04953170411939Single Use Biopsy Forceps FB-456DFB-456DN60083302020-09-29
04953170424724Infrared imaging unitMAJ-2304N57695452021-05-31
04953170428142VISERA ELITE II XENON LIGHT SOURCEOLYMPUS CLV-S200-IRN54270452021-03-03
04953170054358BrushMH-36241168002016-09-21
04953170058783BALLOON3MAJ-2332017-10-12
04953170058882BALLOON3MAJ-2492017-10-12
04953170142628SonoSurg TransducerSonoSurg-T2H-C2017-10-06
04953170208485Cleaning brushMAJ-1534N23010002016-09-21
04953170234859SonoSurg Straight Scissors,Pistol Grip,5mm x 34cmT37712017-10-06
04953170234880SonoSurg Curved Scissors,Pistol Grip,5mm x 34cmT37752017-10-06
04953170234941SonoSurg Straight Scissors,HF,Pistol Grip,5mm x 34cmT39002017-10-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04953170421594HD CAMERA HEADOLYMPUS MEDICAL SYSTEMS CORP.NWB2026-07-22
04250480104200NASCHÖLLY FIBEROPTIC GmbHOWN2025-06-11
04547410513790FUJIFILMFUJIFILM CORPORATIONNWB2025-05-31
04048551411704NAKarl Storz GmbH & Co. KGOWN2025-03-27
04048551436271n.a.Karl Storz GmbH & Co. KGOWN2024-11-28
10884521816725VS3-IRVISIONSENSE LTD.OWN2024-11-11
07613327616682SPYSTRYKER CORPORATIONNWB2024-02-27
07613327616699SPYSTRYKER CORPORATIONNWB2024-02-27
07613327616705SPYSTRYKER CORPORATIONNWB2024-02-27
07613327616712SPYSTRYKER CORPORATIONNWB2024-02-27
07613327616729SPYSTRYKER CORPORATIONNWB2024-02-27
07613327616743SPYSTRYKER CORPORATIONNWB2024-02-27
04250480112861NASCHÖLLY FIBEROPTIC GmbHOWN2024-01-08
04250480112878NASCHÖLLY FIBEROPTIC GmbHOWN2024-01-08
04250480112885NASCHÖLLY FIBEROPTIC GmbHOWN2024-01-08
04250480113592NASCHÖLLY FIBEROPTIC GmbHOWN2024-01-08
04250480113608NASCHÖLLY FIBEROPTIC GmbHOWN2024-01-08
04250480113615NASCHÖLLY FIBEROPTIC GmbHOWN2024-01-08
04250480113622NASCHÖLLY FIBEROPTIC GmbHOWN2024-01-08
04250480113639EleVision™SCHÖLLY FIBEROPTIC GmbHOWN2024-01-08
076133276089151788STRYKER CORPORATIONNWB2023-12-11
04250480109076NASCHÖLLY FIBEROPTIC GmbHOWN2023-10-30
04250480109083NASCHÖLLY FIBEROPTIC GmbHOWN2023-10-30
04250480109045N/ASCHÖLLY FIBEROPTIC GmbHOWN2023-10-24
04582389010871PDE-GEN3HAMAMATSU PHOTONICS K.K.OWN2023-06-01
04953170437960ETO CAPOLYMPUS MEDICAL SYSTEMS CORP.NWB2023-04-22
04953170434754EVIS EXERA III BRONCHOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.NWB2023-04-20
04953170434778EVIS EXERA III BRONCHOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.NWB2023-04-20
04953170434792EVIS EXERA III BRONCHOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.NWB2023-04-20
04953170452031TROCAR INTRODUCER FOR LTF 5MM SCOPE MAJ-1379OLYMPUS MEDICAL SYSTEMS CORP.NWB2022-07-25