Data / Medical devices / France / Quantel Medical
Quantel Medical: FDA-registered device maker in COURNON AUVERGNE Puy-de-Dome, France, 16 510(k) clearances and 1 PMA approval
Quantel Medical is registered with the FDA (registration 9680671) in COURNON AUVERGNE Puy-de-Dome, France. It lists 8 device types. The FDA files 16 510(k) clearances and 1 PMA approval under its listings, the newest dated February 6, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9680671
- FEI number
- 3003465293
- Address
- 1 rue du bois Joli CS40015, COURNON AUVERGNE Puy-de-Dome, France, 63808
- Owner or operator
- QUANTEL MEDICAL (9002489)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- September 15, 1995
- Registered through
- 2026
- Brand names listed
- ABSOLU, ACTIVIS, AVISO, AXIS NANO, AXIS Touch, Axialis, CAPSULO, CINESCAN FAMILY and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Laser, Ophthalmic | HQF | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Light, Examination, Medical, Battery Powered | KYT | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Powered Laser Surgical Instrument With MicrobeamFractional Output | ONG | 2 | Contract manufacturer | accessdata.fda.gov |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | 2 | Manufacturer | accessdata.fda.gov |
| System, Laser, Photodynamic Therapy | MVF | 3 | Manufacturer | accessdata.fda.gov |
| Topographer, Corneal, Ac-Powered | MMQ | 1 | Manufacturer | accessdata.fda.gov |
| Transducer, Ultrasonic, Diagnostic | ITX | 2 | Manufacturer | accessdata.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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 6, 2026 | K251507 | INTEGRE LIO | HQF | Substantially Equivalent | Quantel Medical | accessdata.fda.gov |
| April 26, 2024 | K232302 | Pocket III | IYO | Substantially Equivalent | Quantel Medical | accessdata.fda.gov |
| May 12, 2022 | K220430 | Capsulo | HQF | Substantially Equivalent | Quantel Medical | accessdata.fda.gov |
| November 15, 2021 | K213254 | Axialis Ophthalmic Ultrasound System | IYO | Substantially Equivalent | Quantel Medical | accessdata.fda.gov |
| August 6, 2020 | K201502 | Vitra 810 | HQF | Substantially Equivalent | Quantel Medical | accessdata.fda.gov |
| December 5, 2019 | K191962 | Vitra 2 | GEX | Substantially Equivalent | Quantel Medical | accessdata.fda.gov |
| March 20, 2019 | K183414 | ABSOLU | IYO | Substantially Equivalent | Quantel Medical | accessdata.fda.gov |
| March 2, 2018 | K180265 | COMPACT TOUCH Ophthalmic Ultrasound System | IYO | Substantially Equivalent | Quantel Medical | accessdata.fda.gov |
| July 25, 2017 | K170067 | Easyret | HQF | Substantially Equivalent | Quantel Medical | accessdata.fda.gov |
| June 25, 2014 | K140336 | OPTIMUS FUSION: SLT, YAG AND YAG/SLT | HQF | Substantially Equivalent | Quantel Medical | accessdata.fda.gov |
| August 2, 2013 | K130933 | SOLUTIS | HQF | Substantially Equivalent | Quantel Medical | accessdata.fda.gov |
| July 21, 2010 | K100678 | SUPRA SCAN DELIVERY SYSTEM | GEX | Substantially Equivalent | Quantel Medical | accessdata.fda.gov |
| April 22, 2010 | K094038 | COMPACT TOUCH | IYO | Substantially Equivalent | Quantel S.A. | accessdata.fda.gov |
| June 16, 2009 | K091581 | SUPRA 577.Y LASER | HQF | Substantially Equivalent | Quantel Medical | accessdata.fda.gov |
| August 3, 2005 | K051851 | AVISO OPHTHALMIC ULTRASOUND SYSTEM | IYO | Substantially Equivalent | Quantel Medical | accessdata.fda.gov |
| March 24, 2005 | K043613 | Q-SWITCHED ND:YAG OPHTALMIC LASER (WITH SLIT LAMP), MODEL OPTIMIS II | HQF | Substantially Equivalent | Quantel Medical | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| April 4, 2006 | P050026 | QUANTEL ACTIVIS LASER AND ZSL30 ACT, ZSL120 ACT, AND HSBMBQ ACT SLIT LAMP ADAPTERS | MVF | 3 | February 11, 2025 | accessdata.fda.gov |
Compare with other makers
- All makers of System, Imaging, Pulsed Echo, Ultrasonic
- All makers of Laser, Ophthalmic
- All makers of Transducer, Ultrasonic, Diagnostic
- All makers of Light, Examination, Medical, Battery Powered
- All makers of Topographer, Corneal, Ac-Powered
- All makers of Powered Laser Surgical Instrument
Updated February 6, 2026. 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.