QUANTEL MEDICAL

Address:1 rue du bois Joli,COURNON AUVERGNE Puy-de-Dome,FR

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Laser, Ophthalmic (HQF) (7) Powered Laser Surgical Instrument (GEX) (1) System, Imaging, Pulsed Echo, Ultrasonic (IYO) (1) Transducer, Ultrasonic, Diagnostic (ITX) (1)

Premarket Exempt

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577nm adaptor for Keeler Vantage Plus IO (100µ) - 03700542625408 Catalog Number :

Device Description : 577nm adaptor for Keeler Vantage Plus Indirect Ophthalmoscope (100µ)

Device Class : 2

Duns Number: 738574953

Premarket Exempt : No

Product Code : HQF

Prescription Use : No

Device Count : 1

VITRA MULTISPOT - 03700542625415 Catalog Number :

Device Description : 532nm Multispot LaserRetinal Photocoagulation

Device Class : 2

Duns Number: 738574953

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

532nm VITRA MULTISPOT adaptor - 03700542625422 Catalog Number :

Device Class : 2

Duns Number: 738574953

Premarket Exempt : No

Product Code : HQF

Prescription Use : No

Device Count : 1

532nm VITRA MULTISPOT adaptor for OPTIMIS II coupling - 03700542625439 Catalog Number :

Device Class : 2

Duns Number: 738574953

Premarket Exempt : No

Product Code : HQF

Prescription Use : No

Device Count : 1

532nm VITRA MULTISPOT adaptor for OPTIMIS FUSION coupling - 03700542625446 Catalog Number : 1

Device Class : 2

Duns Number: 738574953

Premarket Exempt : No

Product Code : HQF

Prescription Use : No

Device Count : 1

SOLUTIS - 03700542625453 Catalog Number :

Device Description : Adaptable SLT Laser (Selective Trabeculoplasty - 532nm)

Device Class : 2

Duns Number: 738574953

Premarket Exempt : No

Product Code : HQF

Prescription Use : No

Device Count : 1

OPTIMIS FUSION - 03700542625460 Catalog Number :

Device Description : SLT/YAG Laser(Dual-mode laser cavity, 532nm and 1064nm)

Device Class : 2

Duns Number: 738574953

Premarket Exempt : No

Product Code : HQF

Prescription Use : No

Device Count : 1

EASYRET - 03700542625484 Catalog Number :

Device Description : The laser (577 nm Fiber Techology Laser SingleSpot, MultiSpot and Subliminal mod The laser (577 nm Fiber Techology Laser SingleSpot, MultiSpot and Subliminal mode and Slit Lamp Haag Streit mode) is a photocoagulator device intended for the treatment of retinal diseases.

Device Class : 2

Duns Number: 738574953

Premarket Exempt : No

Product Code : HQF

Prescription Use : No

Device Count : 1

ABSOLU - 03700542625521 Catalog Number :

Device Description : The ABSolu is a high definition multifunction ophthalmic ultrasound system used The ABSolu is a high definition multifunction ophthalmic ultrasound system used for: - Axial Length measurement of the eye by ultrasonic means; - Implanted IOL power calculation, using the axial length measurement; - Visualization of the interior of the eye and the orbit by A and B scans. - ABSOLU S only: Advanced diagnostic - Standardized echography provides detailed information about the internal reflectivity of tissues and allows optimal tissues differentiation, localization and measurement of structures in the eye and orbit.

Device Class : 2

Duns Number: 738574953

Premarket Exempt : No

Product Code : IYO

Prescription Use : No

Device Count : 1

B Probe 15MHz COMPACT TOUCH - 03700542625538 Catalog Number :

Device Description : 15 MHz Probe for eye and orbit examination. Automatic biometry readings obtained 15 MHz Probe for eye and orbit examination. Automatic biometry readings obtained from a B mode image allowing axial length measurements for difficult to mesure long eyes or posterior staphyloma.

Device Class : 2

Duns Number: 738574953

Premarket Exempt : No

Product Code : ITX

Prescription Use : No

Device Count : 1

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