FDA Registration Active 🇫🇷 France

LUNEAU TECHNOLOGY OPERATIONS

Reg #: 3009173773 · FEI: 3009173773 · Expires 2026
Products
12
Proprietary Names
27
Establishment Types
1
Classifications
12

Registration Details

Registration Name
LUNEAU TECHNOLOGY OPERATIONS
Registration Number
3009173773
FEI Number
3009173773
Status
Active
Expiry Year
2026
Initial Importer
No
Address
2 Rue Roger Bonnet
City
Pont-de-l'Arche Eure
Country
FR

Regulatory Submissions

510(k) Number
K143086

Owner / Operator

Firm Name
LUNEAU TECHNOLOGY OPERATIONS
Operator Number
8020811
Address
2 Rue Roger Bonnet
City
Pont-de-l'Arche
State
Eure
Postal Code
27340
Country
FR

US Agent

Business Name
Visionix USA, Inc
Contact Name
Peter G Sparacio
Address
160 Eisenhower Ln N
City
Lombard
State
IL
ZIP
60148
Country
US
Phone
630 5090949

Products

Device Name Product Code
Esthesiometer, Ocular HJC
Tonometer, Ac-Powered HKX
Instrument, Measuring, Lens, Ac-Powered HLM
Chart, Visual Acuity HOX
Biomicroscope, Slit-Lamp, Ac-Powered HJO
Refractometer, Ophthalmic HKO
Camera, Ophthalmic, Ac-Powered HKI
Prism, Bar, Ophthalmic HKW
Tonometer, Manual HKY
Device, Analysis, Anterior Segment MXK
Rack, Skiascopic HMH
Refractor, Manual, Non-Powered, Including Phoropter HKN

Proprietary Names

L12 Aesthesiometer VX120 VX220 DNEye Scanner 2 DNEye Scanner 2+ VX118 VX120+ VX36 VX40 VX40 Pro VX22 VX25 VX70 VX90 VX110 Nexy VX610 Prisms bars Prisms DNEye Scanner 3 VX650 Sterile Tonometer Prisms L900 VX130 VX130+ L2 Skiascopy racks EyeRefract VX65

Establishment Types

Manufacture Medical Device