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Data / Medical devices / France / Sopro

Sopro: FDA-registered device maker in LA CIOTAT CEDEX Bouches-du-Rhone, France, 30 510(k) clearances

Sopro is registered with the FDA (registration 9615782) in LA CIOTAT CEDEX Bouches-du-Rhone, France. It lists 16 device types. The FDA files 30 510(k) clearances under its listings, the newest dated December 14, 2023. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Sopro
FDA registration number
9615782
FEI number
3004084693
Address
Zac Athelia Iv Avenue Des Genevriers, LA CIOTAT CEDEX Bouches-du-Rhone, France, 13705
Owner or operator
SATELEC-ACTEON GROUP (9004992)
Roles
Manufacturer, Repackager or relabeler
First device listed
December 13, 2007
Registered through
2026
Brand names listed
C20 INTRAORAL CAMERA, C50, C50 INTRAORAL CAMERA D, Caries Detection Device, DUO, DiGILAP Titanium, Laser Flourescence Caries Detection, Mini Dock U USB2 and more

Devices it lists

DeviceProduct codeClassRoleSource
ArthroscopeHRX2Manufactureraccessdata.fda.gov
Camera, Television, Endoscopic, Without AudioFWF1Manufactureraccessdata.fda.gov
Endoscopic Video Imaging System/Component, Gastroenterology-UrologyFET2Manufactureraccessdata.fda.gov
Insufflator, LaparoscopicHIF2Manufactureraccessdata.fda.gov
Laparoscope, General & Plastic SurgeryGCJ2Manufactureraccessdata.fda.gov
Led Light SourceNTN2Manufactureraccessdata.fda.gov
Light Source, Fiberoptic, RoutineFCW2Manufactureraccessdata.fda.gov
Light-Induced Fluorescence Caries Detector NBL2Manufactureraccessdata.fda.gov
Plaque Disclosing KitNYH2Manufactureraccessdata.fda.gov
Solid State X-Ray Imager (Flat Panel/Digital Imager)MQB2Repackager or relabeleraccessdata.fda.gov
Source, Carrier, Fiberoptic LightEQH1Manufactureraccessdata.fda.gov
System, X-Ray, Extraoral Source, DigitalMUH2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Tubing/Tubing With Filter, Insufflation, LaparoscopicNKC1Repackager or relabeleraccessdata.fda.gov
Unit, Operative DentalEIA1Manufactureraccessdata.fda.gov
Unit, Operative Dental, AccessoriesNRD1Manufactureraccessdata.fda.gov
Unit, X-Ray, Extraoral With TimerEHD2Repackager or relabeleraccessdata.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
December 14, 2023K223470C50NBLSubstantially EquivalentSoproaccessdata.fda.gov
June 17, 2016K153367S698 Symbioz flowHIFSubstantially EquivalentSopro - Acteon Groupaccessdata.fda.gov
August 17, 2015K142995SOPIXMUHSubstantially EquivalentSopro - Acteon Groupaccessdata.fda.gov
July 31, 2015K151053PSPIX 2 scanner, Imaging Plate Size 0 for PSPIX2 scanner, Imaging Plate Size 1 for PSPIX2 scanner, Imaging Plate Size 2 for PSPIX2 scanner, Imaging Plate Size 3 for PSPIX2 scannerMUHSubstantially EquivalentSopro - Acteon Groupaccessdata.fda.gov
September 5, 2014K140013SOPIX INSIDE, SOPIX2 INSIDEMUHSubstantially EquivalentSopro - Acteon Groupaccessdata.fda.gov
March 12, 2013K121685SOPROCARENBLSubstantially EquivalentSoproaccessdata.fda.gov
March 22, 2011K103813SOPRO 281NTNSubstantially EquivalentSoproaccessdata.fda.gov
July 20, 2010K092329SOPIX 2MUHSubstantially EquivalentSoproaccessdata.fda.gov
January 13, 2010K092583SOPROLIFENBLSubstantially EquivalentSoproaccessdata.fda.gov
April 1, 2009K082796SOPRO 184 CAMERAGCJSubstantially EquivalentSoproaccessdata.fda.gov
July 11, 2008K080122SOPRO 670 ARTHROSCOPIC PUMPHRXSubstantially EquivalentSoproaccessdata.fda.gov
December 13, 2007K070783SOPRO MODEL 640 LAPAROSCOPIC INSUFFLATORHIFSubstantially EquivalentSoproaccessdata.fda.gov
November 16, 2007K072912SOPRO 225 DUAL HALOGEN LIGHT SOURCEGCJSubstantially EquivalentSoproaccessdata.fda.gov
February 20, 2007K070102SOPRO 162 CAMERAGCJSubstantially EquivalentSoproaccessdata.fda.gov
June 15, 2004K041050DIGORA OPTIME (OR DIGORA ONTIME)MUHSubstantially EquivalentSoredex Palodex Group OYaccessdata.fda.gov
September 16, 2003K031593SOPRO 61DGCJSubstantially EquivalentSoproaccessdata.fda.gov
June 14, 2002K020915SOPRO LIGHT SOURCES AND ACCESSORIESGCJSubstantially EquivalentSoproaccessdata.fda.gov
March 14, 2002K020270SOPRO 367D 3CCD FULL DIGITAL ENDOSCOPY CAMERAGCJSubstantially EquivalentSoproaccessdata.fda.gov
December 13, 2001K013090SOPRO 67D OPERATING ROOM CAMERAGCJSubstantially EquivalentSoproaccessdata.fda.gov
October 5, 2001K012505SOPRO595 INTRA ORAL CAMERAEIASubstantially EquivalentSoproaccessdata.fda.gov
March 31, 2000K000424S51D DIGITAL ENDOSCOPY CAMERAGCJSubstantially EquivalentSoproaccessdata.fda.gov
March 31, 2000K000423S52D DIGITAL VIDEO LAPAROSCOPEGCJSubstantially EquivalentSoproaccessdata.fda.gov
March 31, 2000K000422S57D DIGITAL OPERATING ROOM CAMERAGCJSubstantially EquivalentSoproaccessdata.fda.gov
April 21, 1999K990948S575 INTRAORAL DOCKING DENTAL CAMERAEIASubstantially EquivalentSoproaccessdata.fda.gov
January 11, 1999K983625S555 INTRAORAL DENTAL CAMERAEIASubstantially EquivalentSoproaccessdata.fda.gov
January 2, 1998K973796S-41 &41S VIDEO IMAGING SYSTEMGCJSubstantially EquivalentSoproaccessdata.fda.gov
January 2, 1998K973795S-52 ELECTRONIC VIDEO LAPAROSCOPEGCJSubstantially EquivalentSoproaccessdata.fda.gov
January 2, 1998K973794S-57 VIDEO IMAGING SYSTEMGCJSubstantially EquivalentSoproaccessdata.fda.gov
December 3, 1997K973798S-357 VIDEO IMAGING SYSTEMFETSubstantially EquivalentSoproaccessdata.fda.gov
September 18, 1997K972540S-357 VIDEO IMAGING SYSTEMFETSubstantially EquivalentSoproaccessdata.fda.gov

Compare with other makers

Updated December 14, 2023. 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.