Quantel Medical
COURNON AUVERGNE Puy-de-Dome, FR
QUANTEL MEDICAL appears in FDA device records in COURNON AUVERGNE Puy-de-Dome, FR. FDA records list 33 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 33 510(k) clearances for Quantel Medical between 2000 and 2026. The busiest year on record is 2002, with 5. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2000 | 2 |
| 2002 | 5 |
| 2003 | 3 |
| 2005 | 3 |
| 2007 | 2 |
| 2009 | 2 |
| 2010 | 3 |
| 2012 | 1 |
| 2013 | 2 |
| 2014 | 1 |
| 2017 | 1 |
| 2018 | 1 |
| 2019 | 2 |
| 2020 | 1 |
| 2021 | 1 |
| 2022 | 1 |
| 2024 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K251507 | INTEGRE LIO | HQF | Substantially Equivalent | |
| K232302 | Pocket III | IYO | Substantially Equivalent | |
| K220430 | Capsulo | HQF | Substantially Equivalent | |
| K213254 | Axialis Ophthalmic Ultrasound System | IYO | Substantially Equivalent | |
| K201502 | Vitra 810 | HQF | Substantially Equivalent | |
| K191962 | Vitra 2 | GEX | Substantially Equivalent | |
| K183414 | ABSOLU | IYO | Substantially Equivalent | |
| K180265 | COMPACT TOUCH Ophthalmic Ultrasound System | IYO | Substantially Equivalent | |
| K170067 | Easyret | HQF | Substantially Equivalent | |
| K140336 | OPTIMUS FUSION: SLT, YAG AND YAG/SLT | HQF | Substantially Equivalent | |
| K130933 | SOLUTIS | HQF | Substantially Equivalent | |
| K122251 | VITRA MULTISPOT | GEX | Substantially Equivalent | |
| K120825 | SUPRA SCAN DELIVERY SYSTEM | HQF | Substantially Equivalent | |
| K102027 | AXIS NANO OPTHALMIC BIOMETER ULTRASOUND SYSTEM | IYO | Substantially Equivalent | |
| K102198 | COMPACT TOUCH STS | IYO | Substantially Equivalent | |
| K100678 | SUPRA SCAN DELIVERY SYSTEM | GEX | Substantially Equivalent | |
| K091581 | SUPRA 577.Y LASER | HQF | Substantially Equivalent | |
| K081946 | SUPRA TWIN OPHTHALMIC LASER PHOTOCOAGULATOR | HQF | Substantially Equivalent | |
| K073066 | 308 DERMATOLOGICAL EXCIMER SYSTEM | FTC | Substantially Equivalent | |
| K070776 | SUPRA OPHTHALMIC LASER PHOTOCOAGULATOR | HQF | Substantially Equivalent | |
| K051851 | AVISO OPHTHALMIC ULTRASOUND SYSTEM | IYO | Substantially Equivalent | |
| K043613 | Q-SWITCHED ND:YAG OPHTALMIC LASER (WITH SLIT LAMP), MODEL OPTIMIS II | HQF | Substantially Equivalent | |
| K043236 | FREQUENCY DOUBLED ND: YAG PHOTOCOAGULATOR, MODEL VITRA | HQF | Substantially Equivalent | |
| K032260 | ARAMIS II DERMATOLOGICAL LASER | GEX | Substantially Equivalent | |
| K023734 | ARAMIS II DERMATOLOGICAL LASER | GEX | Substantially Equivalent | |
| K023464 | VIRIDIS TWIN OPHTHALMIC PHOTOCOAGULATOR | GEX | Substantially Equivalent | |
| K023094 | IRIDIS OPHTHALMIC PHOTOCOAGULATOR | HQF | Substantially Equivalent | |
| K021650 | ATHOSCAN FOR THE ATHOS LASER CONSTANS COOLING HAND PIECE FOR THE ATHOS LASER | GEX | Substantially Equivalent | |
| K021683 | CINESCAN S | IYO | Substantially Equivalent | |
| K020072 | ATHOS LASER | GEX | Substantially Equivalent | |
| K020071 | VIRIDIS DERMA LASER | GEX | Substantially Equivalent | |
| K993674 | POCKET ULTRASONIC PACHYMETER | IYO | Substantially Equivalent | |
| K000554 | POCKET ULTRASONIC OPHTHALMIC PACHYMETER, BIOMETRY TRANSDUCER FOR POCKET | IYO | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9680671 | 3003465293 | QUANTEL MEDICAL | 1 rue du bois Joli, COURNON AUVERGNE Puy-de-Dome 63808 FR | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- HQFLaser, Ophthalmic
- KYTLight, Examination, Medical, Battery Powered
- FTCLight, Ultraviolet, Dermatological
- GEXPowered Laser Surgical Instrument
- ONGPowered Laser Surgical Instrument With MicrobeamFractional Output
- IYOSystem, Imaging, Pulsed Echo, Ultrasonic
- MVFSystem, Laser, Photodynamic Therapy
- MMQTopographer, Corneal, Ac-Powered
- ITXTransducer, Ultrasonic, Diagnostic
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain