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Luneau Technology Operations: FDA-registered device maker in Pont-de-l'Arche Eure, France, 6 510(k) clearances

Name: Luneau Technology Operations FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Luneau Technology Operations is registered with the FDA (registration 3009173773) in Pont-de-l'Arche Eure, France. It lists 12 device types. The FDA files 6 510(k) clearances under its listings, the newest dated January 29, 2021. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3009173773
Address: 2 Rue Roger Bonnet, Pont-de-l'Arche Eure, France, 27340
Owner or operator: LUNEAU TECHNOLOGY OPERATIONS (8020811)
Roles: Manufacturer
First device listed: October 8, 1984
Registered through: 2026
Brand names listed: DNEye Scanner 2, DNEye Scanner 2+, DNEye Scanner 3, EyeRefract, L12 Aesthesiometer, L2 Skiascopy racks, Nexy, Prisms and more

Devices it lists

Device	Product code	Class	Role	Source
Biomicroscope, Slit-Lamp, Ac-Powered	HJO	2	Manufacturer	accessdata.fda.gov
Camera, Ophthalmic, Ac-Powered	HKI	2	Manufacturer	accessdata.fda.gov
Chart, Visual Acuity	HOX	1	Manufacturer	accessdata.fda.gov
Device, Analysis, Anterior Segment	MXK	2	Manufacturer	accessdata.fda.gov
Esthesiometer, Ocular	HJC	1	Manufacturer	accessdata.fda.gov
Instrument, Measuring, Lens, Ac-Powered	HLM	1	Manufacturer	accessdata.fda.gov
Prism, Bar, Ophthalmic	HKW	1	Manufacturer	accessdata.fda.gov
Rack, Skiascopic	HMH	1	Manufacturer	accessdata.fda.gov
Refractometer, Ophthalmic	HKO	1	Manufacturer	accessdata.fda.gov
Refractor, Manual, Non-Powered, Including Phoropter	HKN	1	Manufacturer	accessdata.fda.gov
Tonometer, Ac-Powered	HKX	2	Manufacturer	accessdata.fda.gov
Tonometer, Manual	HKY	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
January 29, 2021	K202221	VX650	HKI	Substantially Equivalent	Luneau Technology Operations	accessdata.fda.gov
June 8, 2018	K180306	Nexy	HKI	Substantially Equivalent	Next Sight Srl	accessdata.fda.gov
April 24, 2017	K162067	VX130 Ophthalmic Diagnostic Device	HKX	Substantially Equivalent	Luneau Sas	accessdata.fda.gov
June 1, 2015	K143086	VX120 Ophthalmic Diagnostic Device	HKX	Substantially Equivalent	Luneau Sas	accessdata.fda.gov
July 31, 2008	K082031	APPASAMY SLIT LAMP, A1A-11 AND A1A-12 SERIES	HJO	Substantially Equivalent	Appasamy Associates	accessdata.fda.gov
February 20, 2003	K023838	LUNEAU STERILE TONOMETER SEPARATION PRISMS	HKY	Substantially Equivalent	Luneau SA	accessdata.fda.gov

Compare with other makers

Updated January 29, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.