LUNEAU TECHNOLOGY OPERATIONS

Address:2 Rue Roger Bonnet,PONT DE L ARCHE Eure,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

Biomicroscope, Slit-Lamp, Ac-Powered (HJO) (7) Device,Analysis,Anterior Segment (MXK) (2) Refractometer, Ophthalmic (HKO) (2) Tonometer, Ac-Powered (HKX) (2) Tonometer, Manual (HKY) (1)

Premarket Exempt

Clear

VISIONIX - 03664188000039 Catalog Number :

Device Description : The VX130+ is a multifunctional eye diagnostic device. There are several operati The VX130+ is a multifunctional eye diagnostic device. There are several operation modes combined in a single platform: aberrometer, autorefractometer, keratometer, corneal topographer, tonometer, multi-slit pachymeter, tear-film analyzer , and retro illumination.The VX130+ is a multi-function diagnostic device combining wavefront aberometer, cornealtopographer, retro-illuminator, tonometer and pachymeter, indicated for: Measuring the refraction of the eye giving both lower and higher order aberrations Measuring the shape of the cornea Retro-illumination imaging of the eye Measuring the intraocular pressure without contacting the eye for glaucoma evaluation Photographing the eye and taking images of the eye to evaluate the thickness of the central cornea. Full cornea thickness map Scheimpflug imaging Anterior chamber imaging Pupil ImageImage of the cornea relative to the irisAnalysis of the tear film and evaluation of tear film non-invasive tear break-up time (NITBUT)Meibomian glands imagingEvaluation of tear meniscus height

Device Class : 1

Duns Number: 260432380

Premarket Exempt : No

Product Code : HKX, HKO, MXK

Prescription Use : Yes

Device Count : 1

VISIONIX - 03664188000046 Catalog Number :

Device Description : The VX120+ is a multi-function diagnostic device combining corneal topographer, The VX120+ is a multi-function diagnostic device combining corneal topographer, retro-illuminator, tonometer and pachymeter, indicated for: Measuring the refraction of the eye giving both lower and higher order aberrations Measuring the shape of the cornea Retro-illumination imaging of the eye Measuring the intraocular pressure without contacting the eye for glaucoma evaluation. Photographing the eye and taking images of the eye to evaluate the thickness of the cornea.Analysis of the tear film and evaluation of tear film non-invasive tear break-up time (NITBUT)Meibomian glands imagingEvaluation of tear meniscus height

Device Class : 1

Duns Number: 260432380

Premarket Exempt : No

Product Code : HKX, HKO, MXK

Prescription Use : Yes

Device Count : 1

Luneau - 03664188000107 Catalog Number :

Device Description : The separation prisms is an accessory to the tonometer which is device intended The separation prisms is an accessory to the tonometer which is device intended to estimate intraocular pressure by applying a force on the globe of the eye.

Device Class :

Duns Number: 260432380

Premarket Exempt : No

Product Code : HKY

Prescription Use : Yes

Device Count : 100

VISIONIX - 03664188000756 Catalog Number :

Device Description : ophthalmic slit lamp

Device Class : 2

Duns Number: 260432380

Premarket Exempt : No

Product Code : HJO

Prescription Use : Yes

Device Count : 1

VISIONIX - 03664188000763 Catalog Number :

Device Description : ophthalmic slit lamp

Device Class : 2

Duns Number: 260432380

Premarket Exempt : No

Product Code : HJO

Prescription Use : Yes

Device Count : 1

VISIONIX - 03664188000770 Catalog Number :

Device Description : ophthalmic slit lamp

Device Class : 2

Duns Number: 260432380

Premarket Exempt : No

Product Code : HJO

Prescription Use : Yes

Device Count : 1

VISIONIX - 03664188000787 Catalog Number :

Device Description : ophthalmic slit lamp

Device Class : 2

Duns Number: 260432380

Premarket Exempt : No

Product Code : HJO

Prescription Use : Yes

Device Count : 1

VISIONIX - 03664188000800 Catalog Number :

Device Description : ophthalmic slit lamp

Device Class : 2

Duns Number: 260432380

Premarket Exempt : No

Product Code : HJO

Prescription Use : Yes

Device Count : 1

VISIONIX - 03664188000817 Catalog Number :

Device Description : ophthalmic slit lamp

Device Class : 2

Duns Number: 260432380

Premarket Exempt : No

Product Code : HJO

Prescription Use : Yes

Device Count : 1

VISIONIX - 03664188000824 Catalog Number :

Device Description : ophthalmic slit lamp

Device Class : 2

Duns Number: 260432380

Premarket Exempt : No

Product Code : HJO

Prescription Use : Yes

Device Count : 1

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