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510(k) Data Aggregation
K Number
K162067Device Name
VX130 Ophthalmic Diagnostic Device
Manufacturer
LUNEAU SAS
Date Cleared
2017-04-24
(272 days)
Product Code
HKX, MXK
Regulation Number
886.1930Why did this record match?
Applicant Name (Manufacturer) :
LUNEAU SAS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Measuring the refraction of the eye giving both lower and higher order aberrations
Measurement of 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 corneal thickness map.
Scheimpflug imaging.
Anterior chamber imaging.
Pupil image.
Image of the cornea relative to the iris.
Device Description
The VX130 is a multifunctional ophthalmic diagnostic device.
The VX130 combined wavefront aberrometer, corneal topographer, cataract screening device, Scheimpflug pachymeter, and non-contact tonometer is a single platform that contains five different measurement units.
The wavefront aberrometer works on the Shack-Hartmann principle and is used as an advanced autorefractometer that measures both lower and higher order aberrations of the eye. Retro illumination is used to image ocular opacities. The corneal topographer uses a Placido disk to measure keratometry and the detailed shape of the cornea. A linear scanning Scheimpflug pachymeter measures the thickness of the cornea by illuminating it with a slit of light and photographing it using the Scheimpflug technique. Anterior and posterior corneal shape are also measured from the Scheimpflug images. An air puff non-contact tonometer is included for measurement of the intraocular pressure. The device is fully automated and a number of different measurements can be performed by a single command including alignment and focusing.
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K Number
K143086Device Name
VX120 Ophthalmic Diagnostic Device
Manufacturer
LUNEAU SAS
Date Cleared
2015-06-01
(217 days)
Product Code
HKX, HKO, MXK
Regulation Number
886.1930Why did this record match?
Applicant Name (Manufacturer) :
LUNEAU SAS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VX120 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 comea
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.
Device Description
The VX120 is a multifunctional ophthalmic diagnostic device.
The VX120 combined wavefront aberrometer, corneal topographer, retro illumination device, Scheimpflug pachymeter, and non-contact tonometer is a single platform that contains five different measurement units.
The wavefront aberrometer works on the Shack-Hartmann principle and is used as an advanced autorefractometer that measures both lower and higher order aberrations of the refraction of the eye.
Retro illumination is used to image ocular opacities.
The corneal topographer uses a Placido disk to measure keratometry and the detailed shape of the cornea.
The Scheimpflug pachymeter measures the thickness of the central cornea by illuminating it with a slit of light and photographing it using the Scheimpflug technique. An air puff non-contact tonometer is included for measurement of the intraocular pressure.
The device is fully automated and a number of different measurements can be performed by a single command including alignment and focusing.
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K Number
K023838Device Name
LUNEAU STERILE TONOMETER SEPARATION PRISMS
Manufacturer
LUNEAU SA
Date Cleared
2003-02-20
(94 days)
Product Code
HKY
Regulation Number
886.1930Why did this record match?
Applicant Name (Manufacturer) :
LUNEAU SA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Indications for use :
The tonometer separation prisms is an accessory to the tonometer which is a manual device used to measure the intraocular pressure of the eye.
Device Description
The Luneau tonometer separation prisms is an optical plastic monobloc piece which is transparent made of 1 plane surface in contact with the eye and of 2 small prisms allowing the ophthalmologists to observe 2 half circles.
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K Number
K022413Device Name
LUNEAU 3 MIRROR LENS
Manufacturer
LUNEAU SA
Date Cleared
2002-09-24
(62 days)
Product Code
HJK
Regulation Number
886.1385Why did this record match?
Applicant Name (Manufacturer) :
LUNEAU SA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 3-Mirror Lens is an ophthalmic device used for the examination of the ocular fundus.
Device Description
The 3-Mirror Lens is an optical device, which by the intermidiary of the mirrors, allows the ophthalmologist to observe different parts of the posterior chamber of the eye, in particular, the retina. The ophthalmologist holds the 3-Mirror Lens with his hand on the eye of the patient and he observes the images from the mirrors with a slit-lamp.
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