FDA.reportPublic FDA data

COMEG MEDICAL TECHNOLOGIES

Primary DI
03760278260342
Brand
COMEG MEDICAL TECHNOLOGIES
Company
SOPRO
Model
PENTAX Medical LED Light Source
Catalog number
S_281P_0104
Device description
"""This 30 Watt LED light source has been especially designed for endoscopic diagnosis applications in medical practices of the following special fields: ent, gynecology, urology, veterinary. It is equipped with an electronic iris with fibre optic sensor, an automatic thermal protection system and a power level memory."""
Published
2019-07-16
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
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
K103813000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K103813000SOPRO 281Sopro2011-03-22NTN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03760278260342PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760278260342037602782603423760278260342

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
+33556340607info@acteongroup.com

Regulatory Flags#

DUNS number
264205501
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03760278260434ACTEON SYSTEME PSPIX WIN MAC (Only)9970902018-11-19
03760278260939ACTEON SYSTEME PSPIX WIN MACS_702_00112018-11-19
M430S70200111ACTEON SYSTEME PSPIX WIN MACS_702_00112016-09-24
03760278267587ACTEONC50 - INTRAORAL CAMERAS_C50_00082024-05-02
03760278267594ACTEONC50 - INTRAORAL CAMERA DS_C50_00092024-05-02
03760278267020ACTEONC50 - INTRAORAL CAMERA DS_C50_00022022-09-01
03760278267037ACTEONC50 - INTRAORAL CAMERA DS_C50_00022022-09-01
03760278260045COMEG MEDICAL TECHNOLOGIESUBIPACK ENT SYSTEMSK1010162017-12-19
03760278260427COMEG MEDICALSOURCE LED SOPRO 281 BLANC (Only)9983602018-11-19
M430S21800061COMEG MEDICALSOPRO 218 - SOURCE DE LUMIERE XENON 180W - SOPRO S_218_00062016-09-24
M430S21800091COMEG MEDICALS218 SOPRO US OLYMPUSS_218_00092016-09-24
M430S21800111COMEG MEDICALS218 SOPRO US OLYMPUSS_218_00112016-09-24
M430S21800121COMEG MEDICALS218 SOPRO US WOLFS_218_00122016-09-24
M430S23000051COMEG MEDICALSOPRO 230 - SOURCE DE LUMIERE XENON 300W - SOPROS_230_00052016-09-24
M430S23000091COMEG MEDICALS230 SOPRO US OLYMPUSS_230_00092016-09-24
M430S23000111COMEG MEDICALS230 SOPRO US WOLFS_230_00112016-09-24
M430S28100011COMEG MEDICALSOURCE LED SOPRO 281 ORLS_281_00012016-09-24
M430S28100021COMEG MEDICALSOURCE LED SOPRO 281 BLANCS_281_00022016-09-24
M430S29800021COMEG MEDICALSOURCE LED SOPRO S298S_298_00022016-09-24
03760278260380COMEG MEDICAL TECHNOLOGIESPENTAX Medical USB CameraS_181P_01122019-07-16

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
06970462546207Image ProcessorShenzhen HugeMed Medical Technical Development Co., Ltd.NTN2024-06-11
04250480113530N/ASCHÖLLY FIBEROPTIC GmbHNTN2024-01-08
04250480113677EleVision™SCHÖLLY FIBEROPTIC GmbHNTN2024-01-08
04250480109045N/ASCHÖLLY FIBEROPTIC GmbHFCW2023-10-24
08033638801048Pen LEDSAPI MED SPANTN2023-08-02
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
03760278260861COMEG MEDICAL TECHNOLOGIESSOPROFCW2019-07-16
04048551033821n.a.Karl Storz GmbH & Co. KGFCW2019-02-23