essilorusa.comDigital C.R.P - The digital Corneal Reflection Pupillometer (CRP) enables the Eyecare professional to obtain a measurement of a patient's monocular and binocular pupillary distance and displays them digitally.
2026-04-09
ESSILOR INTERNATIONAL, S.A.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3004741385 | 3004741385 | ESSILOR INTERNATIONAL, S.A. | 1 | N | 2026-01-01 | RUE FERNAND HOLWECK DIJON Cote-d'Or FR 21100 |
| 3010227033 | 3010227033 | ESSILOR International Usine de la Compasserie | 1 | N | 2026-01-01 | 55 Boulevard de l'Ornain Ligny en Barrois Meuse FR 55500 |
| 1000232074 | 1000232074 | Essilor International | 1 | N | 2020-04-25 | 3 Rue du Remblai BP 17354 - Cargo 3 - Bat 3 Cedex Ile-de-France FR 95706 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 03615020000014 | AKR 550 - AKR550 is intended to objectively measure the refractive power of the eye and to measure the corneal curvature radius | 817-262-3801 | John.Anderson@essilorusa.com |
| 03615020000113 | CP 550 - CP 550 is intended to display of acuity optotypes for visual acuity testing. | 817-262-3801 | John.Anderson@essilorusa.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 151867 | 1544587606 | K992836 | SL990, SL980, SL950 | HJO | 1999-11-09 |
| 151867 | 1889186950 | K893172 | VISTA OPHTHALMOSCOPE (BATTERY AND AC-POWERED) | HLI | 1989-06-05 |
| 151867 | 1739885604 | K893171 | VISTA STREAK RETINOSCOPE (AC-POWERED) | HKL | 1989-09-21 |
| 151867 | 1851872886 | K180306 | Nexy | HKI | 2018-06-08 |
| 151867 | 1948343903 | K170164 | 3D OCT-1 Maestro | OBO | 2017-03-03 |
| 151867 | 1093979377 | K152429 | Slit Lamp Microscope | HJO | 2016-05-11 |
| 151867 | 1666974992 | K143086 | VX120 Ophthalmic Diagnostic Device | HKX | 2015-06-01 |
| 151867 | 1992256151 | K142179 | D-KAT Z-YPE | HKY | 2014-09-17 |
| 151867 | 2044398841 | K133667 | SLIT LAMP SL-D701 | HJO | 2014-08-26 |
| 151867 | 1879467228 | K133234 | T-TYPE D-KAT, R-TYPE D-KAT | HKY | 2014-02-21 |
| 151867 | 1980446280 | K132987 | COBRA FUNDUS CAMERA | HKI | 2014-07-03 |
| 151867 | 1362358506 | K100500 | PSL CLASSIC SLIT LAMP | HJO | 2010-03-09 |
| 151867 | 1164265383 | K100439 | MEDIWORKS SLIT LAMP | HJO | 2010-07-16 |
| 151867 | 1041047800 | ||||
| 151867 | 1098746143 | ||||
| 151867 | 1158404461 | ||||
| 151867 | 1243133446 | ||||
| 151867 | 1361121953 | ||||
| 102555 | 1380202034 | ||||
| 151867 | 1566126124 | ||||
| 151867 | 1698025361 | ||||
| 151867 | 1767014693 | ||||
| 151867 | 1773288031 | ||||
| 151867 | 1878334351 | ||||
| 151867 | 1983187417 | ||||
| 151867 | 1002678968 | ||||
| 151867 | 1093979377 | ||||
| 151867 | 1164265383 | ||||
| 151867 | 1362358506 | ||||
| 8989 | 1380202034 | ||||
| 151867 | 1504620613 | ||||
| 151867 | 1544587606 | ||||
| 151867 | 1666974992 | ||||
| 151867 | 1739885604 | ||||
| 151867 | 1879467228 | ||||
| 151867 | 1889186950 | ||||
| 151867 | 1992256151 |
Product Codes Associated With Registrations#
GUDID#
AKR 550 - AKR550 is intended to objectively measure the refractive power of the eye and to measure the corneal curvature radius
2026-02-23
CP 550 - CP 550 is intended to display of acuity optotypes for visual acuity testing.
2026-02-23
AKR 800 - AKR800 is intended to objectively measure the refractive power of the eye and to measure the corneal curvature radii.
2026-02-23
Essilor Stellest - Prescription spectacle lenses to reduce the progression of myopia consist of spectacle lenses with additional physical optical design lens elements. In addition to optical correction of myopic refractive error, these lenses are intended to be used by children who have myopia to reduce the rate of myopia progression. The lenses are mounted within a spectacle frame classified under 886.5842.
2025-10-16
Essilor Stellest - Prescription spectacle lenses to reduce the progression of myopia consist of spectacle lenses with additional physical optical design lens elements. In addition to optical correction of myopic refractive error, these lenses are intended to be used by children who have myopia to reduce the rate of myopia progression. The lenses are mounted within a spectacle frame classified under 886.5842
2025-10-16
Essilor Stellest - Prescription spectacle lenses to reduce the progression of myopia consist of spectacle lenses with additional physical optical design lens elements. In addition to optical correction of myopic refractive error, these lenses are intended to be used by children who have myopia to reduce the rate of myopia progression. The lenses are mounted within a spectacle frame classified under 886.5842.
2025-10-16
WAVE ANALYZER MEDICA 800 - The WAM800 is a multifunctional ophthalmic device. There are several operation modes combined in a single platform :- Aberrometer- Autorefractometer keratometer- Corneal topographer- Tonometer- Pachymeter- Retro-illumination
2023-07-25
WAVE ANALYZER MEDICA 700 PLUS - The WAM700 is a multifunctional ophthalmic device. The machine is a combination of 5 technologies :- Shack Hartmann technology : to measure both low and high order aberrations of the eye, to measure refraction.- Placido disks : for keratometry and for corneal topography measurement.- Non-contact tonometer.- Scheimpflug image : for anterior chamber analysis (pachymetry, irido corneal angle).- Retro illumination : for detection of opacity.Measurement is fully automatic using image processing software and fully automated motors for centering and focusing. The machine includes a fixation target with automatic fogging for accommodation control.
2016-09-23
ESSILOR RETINA 400 - "Retina 400 is an electromedical system that allows for digitally retrieving, acquiring and processing of a retinal image, for use in ophthalmological diagnosis by medical specialists, and other uses inherent to the professional activity of other operators, optometrists and opticians, to the extent permitted by the laws and regulations for the exercise of their profession.An absolute new entry in the field for retinal imaging, the instrument allows for a direct, ""live"" monitoring on the computer screen, and capturing also in cases where the pupil diameter is extremely narrow. The instrument, with manual acquisition and electronically guided control, guarantees high precision and repeatability of the measurements."
2016-09-23
ESSILOR RETINA 800 - Retina 800 is an automatic eye-fundus camera intended for taking digital images of a human retina without the use of a mydriatic agent
2020-04-02
OCT500 - 3D Optical Coherence Tomography OCT500 is a non-contact, high-resolution tomographic and biomicroscopic imaging device. It is indicated for in-vivo viewing, axial cross-sectional and three dimensional imaging, and measurement of posterior ocular structures, including the retina, retinal nerve fiber layer, ganglion cell plus inner plexiform layer, ganglion cell complex, macula, optic nerve head. It is also indicated for in-vivo viewing, axial cross-sectional and three dimensional imaging of anterior ocular structures, including the cornea.The instrument is intended for use as a diagnostic device to aid in the detection and management of ocular diseases including, but not limited to, macular holes, cystoid macular edema, diabetic retinopathy, agerelated macular degeneration, and glaucoma.
2020-03-23
ALM500 - This device aims to take the measurements of SPH, CYL, AXIS, prism refractive power and optical axis coordinate of unprocessed lens, processed framed lens and contact lens, and to put dots on them to find its axis
2023-10-03
ALM700 - This device aims to take the measurements of SPH, CYL, AXIS, prism refractive power and optical axis coordinate of unprocessed lens, processed framed lens and contact lens, and to put dots on them to find its axis
2023-10-03
ALM800 - This device aims to take the measurements of SPH, CYL, AXIS, prism refractive power and optical axis coordinate of unprocessed lens, processed framed lens and contact lens, and to put dots on them to find its axis.It also performs automatic discrimination of progressive lens, pupillary distance (PD) measurement of glass lens, UV cut percentage measurement, blue light which harmful to eyes cut percentage measurement, blue light transmittance measurement which necessary to adjust the circadian rhythm
2023-10-03
Vision-C 600 - Vision-C 600 (VRS001) is a visual chart system, stand-alone type, which displays broad range of charts, based on LCD panel.
2023-09-28
Vision-R 800 - Vision-R 800 is intended to perform a subjective assessment of ametropia or visual function capability
2023-09-11
Vision-R 700 - Vision-R 700 is intended to perform a subjective assessment of ametropia or visual function capability
2023-09-11
Vision-S 700 - Vision-S 700 is a Compact Refraction System used to determine the refractive error and binocular
2023-09-11
Vision-R 800 - Vision-R 800 is intended to perform a subjective assessment of ametropia or visual function capability
2023-09-11
Vision-R 700 - Vision-R 700 is intended to perform a subjective assessment of ametropia or visual function capability
2023-09-11
ESSILOR SL300H - Slit lamp microscopes are used to observe the disease of the anterior structures and tissue damage of eyes
2016-09-23
ESSILOR SL300L - Slit lamp microscopes are used to observe the disease of the anterior structures and tissue damage of eyes
2016-09-23
ESSILOR SL350H - Slit lamp microscopes are used to observe the disease of the anterior structures and tissue damage of eyes
2016-09-23
ESSILOR SL350L - Slit lamp microscopes are used to observe the disease of the anterior structures and tissue damage of eyes
2016-09-23
ESSILOR SL400H - Slit lamp microscopes are used to observe the disease of the anterior structures and tissue damage of eyes
2016-09-23
ESSILOR SL400L - Slit lamp microscopes are used to observe the disease of the anterior structures and tissue damage of eyes
2016-09-23
ESSILOR SL450H - Slit lamp microscopes are used to observe the disease of the anterior structures and tissue damage of eyes
2016-09-23
ESSILOR SL450L - Slit lamp microscopes are used to observe the disease of the anterior structures and tissue damage of eyes
2016-09-23
ESSILOR SL500L - Stereomicroscopic observation of the eye subjected to light through a slotMicroscopic study of the fundus and posterior vitreous (via a lens Hubry)The ophthalmic evaluation and positioning of the contact lensThis product is used by ophthalmologists and opticians (in their professional skills) to perform specific diagnostics in ophthalmology (biomicroscopy of the eye).
2016-09-23
ESSILOR SL550L - Stereomicroscopic observation of the eye subjected to light through a slotMicroscopic study of the fundus and posterior vitreous (via a lens Hubry)The ophthalmic evaluation and positioning of the contact lensThis product is used by ophthalmologists and opticians (in their professional skills) to perform specific diagnostics in ophthalmology (biomicroscopy of the eye).
2016-09-23
ANAEYES OCT for system linkage - ANAEYES OCT
2021-02-18