VX650
Luneau Technology Operations
LUNEAU TECHNOLOGY OPERATIONS
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3009173773 | 3009173773 | LUNEAU TECHNOLOGY OPERATIONS | 1 | N | 2026-01-01 | 2 Rue Roger Bonnet Pont-de-l'Arche Eure FR 27340 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 139087 | 1914867852 | K992836 | SL990, SL980, SL950 | HJO | 1999-11-09 |
| 139087 | 1680808051 | K202221 | VX650 | HKI | 2021-01-29 |
| 139087 | 1242731838 | K180306 | Nexy | HKI | 2018-06-08 |
| 139087 | 1747772817 | K162067 | VX130 Ophthalmic Diagnostic Device | HKX | 2017-04-24 |
| 139087 | 1551023152 | K143086 | VX120 Ophthalmic Diagnostic Device | HKX | 2015-06-01 |
| 139087 | 1145333026 | K082031 | APPASAMY SLIT LAMP, A1A-11 AND A1A-12 SERIES | HJO | 2008-07-31 |
| 139087 | 1683824101 | K023838 | LUNEAU STERILE TONOMETER SEPARATION PRISMS | HKY | 2003-02-20 |
| 139087 | 1063227757 | ||||
| 139087 | 1245889398 | ||||
| 139087 | 1253905528 | ||||
| 139087 | 1343511674 | ||||
| 139087 | 1671832150 | ||||
| 139087 | 1867762076 | ||||
| 139087 | 1950958352 | ||||
| 139087 | 2024954633 |
Product Codes Associated With Registrations#
PMN#
GUDID#
Visionix - The VX120+ is a multi-function diagnostic device combining corneal topographer, retro-illuminator, 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.
2023-06-08
Visionix VX650 - VX650
2023-06-08
VISIONIX - VX40 Pro
2025-09-05
ZEISS - VISUREF 1000
2025-03-11
Luneau - 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.
2023-06-08
VISIONIX - The VX65 is an automatic phoropter, to measure the subjective refraction, it is used as an ophthalmic device.
2025-01-02
VISIONIX - VX90 is an ophthalmic diagnostic device, autorefracto-keratometer
2025-01-02
Luneau - Measurement of corneal sensation, specifically tactile.
2025-01-02
ESSILOR - Automatic eye-fundus camera and software intended for photographing, displaying,and storing images of the retina without the use of a mydriatic agent.
2025-01-02
ESSILOR - WAM700+ is a multifunctional eye diagnostic device.
2025-01-02
ESSILOR - WAM800 is a multifunctional eye diagnostic device.
2025-01-02
Visionix - VX610
2024-04-30
Visionix - EyeRefract
2023-06-15
Visionix - ophthalmic slit lamp
2023-06-08
Visionix - ophthalmic slit lamp
2023-06-08
Visionix - ophthalmic slit lamp
2023-06-08
Visionix - Chart Display
2023-06-08
Visionix - Chart Display
2023-06-08
Visionix - Skiascopy racks
2023-06-08
Visionix - Chart Display
2023-06-08
Visionix - Chart Display
2023-06-08
Visionix - Chart Display
2023-06-08
Visionix - VX40
2023-06-08
Visionix - Nexy
2023-06-08
Visionix - PRISM BARS SET (HORIZ. + VERT) + 2 add prisms 40 a
2023-06-08
RODENSTOCK - DNEye Scanner 3
2023-06-08
Carl Zeiss Meditec - Velara 200
2023-06-08
Visionix - Prism Bar Set horiz./vertical
2023-06-08
Visionix - Prism Bar horizontal
2023-06-08
Visionix - Prism Bar vertical
2023-06-08
Visionix - VX40 APS
2023-06-08
RODENSTOCK - 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 iris
2023-06-08
RODENSTOCK - DNEye Scanner 2+
2023-06-08
VISIONIX - 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
2020-05-25
VISIONIX - 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
2020-05-25
VISIONIX - 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
2020-05-25
Luneau - 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.
2016-09-23
VISIONIX - ophthalmic slit lamp
2016-09-23
VISIONIX - ophthalmic slit lamp
2016-09-30
VISIONIX - ophthalmic slit lamp
2016-09-30