LUNEAU TECHNOLOGY OPERATIONS

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

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Filters

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) (5) Tonometer, Ac-Powered (HKX) (4) Device,Analysis,Anterior Segment (MXK) (3) Refractometer, Ophthalmic (HKO) (3)

Premarket Exempt

Clear

VISIONIX - 03664188000831 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 - 03664188000855 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 - 03664188000862 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 - 03664188000879 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 - 03664188000886 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 - 03664188000909 Catalog Number :

Device Description : The VX130 is a multi-function diagnostic device combining wavefront aberometer, The VX130 is a multi-function diagnostic device combining wavefront aberometer, 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 centralcornea. Full cornea thickness map Scheimpflug imaging Anterior chamber imaging Pupil ImageImage of the cornea relative to the iris

Device Class : 1

Duns Number: 260432380

Premarket Exempt : No

Product Code : HKX, HKO, MXK

Prescription Use : Yes

Device Count : 1

VISIONIX - 03664188001180 Catalog Number :

Device Description : The VX118 is a multifunctional eye diagnostic device. There are several operatio The VX118 is a multifunctional eye diagnostic device. There are several operation modes combined in a single platform: aberrometer, autorefracter keratometer, corneal topographer, pachymeter and retro illumination.

Device Class : 1

Duns Number: 260432380

Premarket Exempt : No

Product Code : HKX, HKO

Prescription Use : Yes

Device Count : 1

VISIONIX - 03664188001203 Catalog Number :

Device Description : The VX120 is a multifunctional eye diagnostic device. There are several operatio The VX120 is a multifunctional eye diagnostic device. There are several operation modes combined in a single platform: aberrometer, autorefracter keratometer, corneal topographer, tonometer, pachymeter and retro illumination.

Device Class : 1

Duns Number: 260432380

Premarket Exempt : No

Product Code : HKX, HKO, MXK

Prescription Use : Yes

Device Count : 1

VISIONIX - 03664188002200 Catalog Number :

Device Description : The VX220 is a multifunctional eye diagnostic device. There are several operatio The VX220 is a multifunctional eye diagnostic device. There are several operation modes combined in a single platform: keratometer, corneal topographer, tonometer,and pachymeter and retro illumination

Device Class : 2

Duns Number: 260432380

Premarket Exempt : No

Product Code : HKX, MXK

Prescription Use : Yes

Device Count : 1

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