VISIONIX

GUDID 03664188000909

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 central cornea. Full cornea thickness map Scheimpflug imaging Anterior chamber imaging Pupil Image Image of the cornea relative to the iris

LUNEAU TECHNOLOGY OPERATIONS

Ophthalmic refractometer, automated Ophthalmic refractometer, automated Ophthalmic refractometer, automated Ophthalmic refractometer, automated Ophthalmic refractometer, automated Ophthalmic refractometer, automated Ophthalmic refractometer, automated Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer

• Primary Device ID: 03664188000909
• NIH Device Record Key: a06715ef-136a-41eb-9b3b-30a2d01b7a69
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VISIONIX
• Version Model Number: VX130
• Company DUNS: 260432380
• Company Name: LUNEAU TECHNOLOGY OPERATIONS
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	03664188000909 [Primary]

FDA Product Code

• HKX: Tonometer, Ac-Powered

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-06-02
• Device Publish Date: 2020-05-25

On-Brand Devices [VISIONIX]

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• 03664188000824: ophthalmic slit lamp
• 03664188000817: ophthalmic slit lamp
• 03664188000800: ophthalmic slit lamp
• 03664188000787: ophthalmic slit lamp
• 03664188000770: ophthalmic slit lamp
• 03664188000763: ophthalmic slit lamp
• 03664188000756: ophthalmic slit lamp
• 03664188000909: The VX130 is a multi-function diagnostic device combining wavefront aberometer, corneal topograp
• 03664188000046: The VX120+ is a multi-function diagnostic device combining corneal topographer, retro-illuminato
• 03664188000039: The VX130+ is a multifunctional eye diagnostic device. There are several operation modes combine
• 03664188000541: VX40 APS
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• 03664188000459: Prism Bar horizontal
• 03664188000442: Prism Bar Set horiz./vertical
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• 03664188000398: PRISM BARS SET (HORIZ. + VERT) + 2 add prisms 40 a
• 03664188000381: Nexy
• 03664188000329: VX40
• 03664188000251: Chart Display
• 03664188000244: Chart Display
• 03664188000237: Chart Display
• 03664188000220: Skiascopy racks
• 03664188000176: Chart Display
• 03664188000152: Chart Display
• 03664188000091: ophthalmic slit lamp
• 03664188000060: The VX120+ is a multi-function diagnostic device combining corneal topographer, retro-illuminato
• 03664188000015: ophthalmic slit lamp
• 03664188000008: ophthalmic slit lamp
• 03664188000084: EyeRefract