Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010227033

FEI Number

3010227033

Entity Name

ESSILOR International Usine de la Compasserie

City/State/Country

Ligny en Barrois Meuse, FR

Establishment Address

55 Boulevard de l'Ornain, Ligny en Barrois Meuse 55500, FR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Essilor International (Owner Number: 10042939)

Owner / Operator Contact Address

81 boulevard Jean Baptiste Oudry, Créteil, FR-IDF 94000, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

AKR 300 AKR1JR AKR 550 SL 550 SL 500 DAT 500 Z DAT 500 T DAT 500 R RET 500 OSC702 OST OSC 600 OSC 701 DAT 500 Z ESS 304 - UB4 ESS 167 ESS 260 ESS 026 ESS 205 N/A EYE RULER 2 X81705 NEAR VISION TABLET 3 VO3 MLM 150 ALM 700 ALM 500 ALM 800 MAG 302 OPTEC MAG 303 Ergovision MAG 301 Campitest FVA Visiotest Cornea 550 + SL 450 SL 650+ SL 300 DEM 650 SL 400 SL 650 SL 350 PSL 500 Vision-R 800 APH 550 MPH 150 Vision-R 700 Vision-S 700 OPH 700 OPH 500

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HKO	Refractometer, Ophthalmic	Ophthalmic	Class 1	886.1760	2013-01-14
HJO	Biomicroscope, Slit-Lamp, Ac-Powered	Ophthalmic	Class 2	886.1850	2015-10-20
HKY	Tonometer, Manual	Ophthalmic	Class 2	886.1930	2015-08-19
HKL	Retinoscope, Ac-Powered	Ophthalmic	Class 2	886.1780	2015-08-19
HMF	Stand, Instrument, Ac-Powered, Ophthalmic	Ophthalmic	Class 1	886.1860	2013-01-14
HKY	Tonometer, Manual	Ophthalmic	Class 2	886.1930	2015-08-19
HPA	Frame, Trial, Ophthalmic	Ophthalmic	Class 1	886.1415	2013-12-26
HJO	Biomicroscope, Slit-Lamp, Ac-Powered	Ophthalmic	Class 2	886.1850	2014-12-29
HLG	Pupillometer, Ac-Powered	Ophthalmic	Class 1	886.1700	2013-01-14
HLM	Instrument, Measuring, Lens, Ac-Powered	Ophthalmic	Class 1	886.1425	2015-09-11
HIT	Tester, Color Vision	Ophthalmic	Class 1	886.1170	2015-10-20
HLQ	Keratoscope, Ac-Powered	Ophthalmic	Class 1	886.1350	2014-12-29
HJO	Biomicroscope, Slit-Lamp, Ac-Powered	Ophthalmic	Class 2	886.1850	2016-05-25
HJO	Biomicroscope, Slit-Lamp, Ac-Powered	Ophthalmic	Class 2	886.1850	2015-08-19
HKN	Refractor, Manual, Non-Powered, Including Phoropter	Ophthalmic	Class 1	886.1770	2013-01-14
HLI	Ophthalmoscope, Ac-Powered	Ophthalmic	Class 2	886.1570	2015-08-19
OUG	Medical Device Data System	General Hospital	Class 1	880.6310	2025-12-04

Official Correspondent

Aurelie JARDIN

US Agent Details

John Anderson Email: john.anderson@essilorusa.com Phone: (817) 2623801

Related Public Records

Same Entity

Essilor International

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K142953	Optomedical Technologies GmbH	OCT-Camera	2015-03-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-2018	Optovue, Inc.	2	iVue with Normative Database, Device Listing Number D185549. Product Usage: The iVue (K121739) is a non-contact, high resolution tomographic imaging device. It is intended for in vivo imaging, axial cross-sectional, and three dimensional imaging and measurement of anterior and posterior ocular structures, including retina, retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, cornea, and anterior chamber of the eye. The iVue with Normative Database is a quantitative tool for the comparison of retina, retinal nerve fiber layer, ganglion cell complex, and optic disc measurements to a database of known normal subjects. The iVue with Normative Database is indicated for use as a device to aid in the diagnosis, documentation, and management of ocular health and diseases in the adult population.
Z-0010-2018	Optovue, Inc.	2	iVue 500 with iScan, D216606. Product non-contact, high resolution tomographic imaging device. It is intended for in vivo imaging, axial cross-sectional and three-dimensional imaging and measurement of anterior and posterior ocular structures, including retina, retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, cornea, and anterior chamber of the eye. The iVue 500 with normative database is a quantitative tool for the comparison of retina, retinal nerve fiber layer, ganglion cell complex, and optic disc measurements to a database of known normal subjects. The iVue 500 with normative database is indicated for use as a device to aid in the diagnosis, documentation, and management of ocular health and diseases in the adult population.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010227033. Last updated year: 2026. Please use registration number 3010227033 when referencing this establishment in official correspondence.