FDA.reportPublic FDA data

RODENSTOCK

Primary DI
03664188000930
Brand
RODENSTOCK
Company
LUNEAU TECHNOLOGY OPERATIONS
Model
DNEye Scanner 2+
Published
2023-06-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HKORefractometer, Ophthalmic
HKXTonometer, Ac-Powered
MXKDevice, Analysis, Anterior Segment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HKORefractometer, OphthalmicOphthalmic1
HKXTonometer, Ac-PoweredOphthalmic2
MXKDevice, Analysis, Anterior SegmentOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162067000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162067000VX130 Ophthalmic Diagnostic DeviceLuneau Sas2017-04-24HKX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03664188000930PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03664188000930036641880009303664188000930

GMDN Terms#

Term, Definition table
TermDefinition
Automated ophthalmic refractometerAn electrically-powered, ophthalmic device designed to be used by a healthcare professional to objectively measure the refractive error of the eye (the inaccuracies of focusing light upon the retina) by measuring how light is changed when it enters the patient's eye(s). The device emits light into the eye and detects the light reflection which is measured for sphere, cylinder, axis and/or high order aberration measurements, typically measured in dioptres (the reciprocal of the focal length of the lens expressed in metres). Also known as an aberrometer, the device uses this information to automatically calculate the lens prescription needed to correct the patient's vision.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
260432380
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03664188000060VisionixVX1102023-06-08
03664188000145Visionix VX650VX650100058442023-06-08
03664188000602VISIONIXVX40 Pro2025-09-05
03664188000589ZEISSVISUREF 10002025-03-11
03664188000138LuneauTonometer separation prisms L900 -box of 202023-06-08
03664188000077VISIONIXVX652025-01-02
03664188000169VISIONIXVX902025-01-02
03664188000312LuneauL12 Aesthesiometer2025-01-02
03664188000435ESSILORRetina 800RET1IN2025-01-02
03664188000558ESSILORWAM 700+2025-01-02
03664188000565ESSILORWAM 8002025-01-02
03664188000411VisionixVX6102024-04-30
03664188000084VisionixEyeRefract2023-06-15
03664188000008VisionixVX70 2x2023-06-08
03664188000015VisionixVX70 5x2023-06-08
03664188000091VisionixVX70 3x2023-06-08
03664188000152VisionixVX222023-06-08
03664188000176VisionixVX252023-06-08
03664188000220VisionixL2 Skiascopy racks2023-06-08
03664188000237VisionixVX22-NP2023-06-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06972039971092MOPTIMShenzhen CERTAINN Technology Co., Ltd.HKO2026-06-03
00860003630624BOSSIntelon Optics, Inc.MXK2026-05-22
04719872711230MiiSMEDIMAGING INTEGRATED SOLUTION INC.HKX2026-04-29
06971922136334YEASNChongqing Yeasn Science & Technology Co.,Ltd.HKO2026-04-25
04719876420046TonoVueCRYSTALVUE MEDICAL CORPORATIONHKX2026-04-15
04049584034953Pentacam Cornea OCTOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungMXK2026-03-31
03615020000014AKR 550ESSILOR INTERNATIONALHKO2026-02-23
03615020000441AKR 800ESSILOR INTERNATIONALHKO2026-02-23
08800019600954Vision ScreenerHuvitz Co., Ltd.HKO2026-02-13
B43050085700GoCheck KidsGobiquity, Inc.HKO2026-01-09
04987669204610Open-field Refraction SystemNIDEK CO.,LTD.HKO2026-01-08
04987669204917Open-field Refraction SystemNIDEK CO.,LTD.HKO2026-01-08
06430033851920iCare ST500ICARE FINLAND OYHKX2025-12-05
04560126269188AUTO KERATO-REFRACTOMETER KR-1TOPCON CORPORATIONHKO2025-11-21
B43071000030GoCheck MultiScreenerGobiquity, Inc.HKO2025-11-19
04571130283343AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIATOPCON CORPORATIONMXK2025-11-17
04571130283343AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIATOPCON CORPORATIONHKX2025-11-17
B43050085610GoCheck KidsGobiquity, Inc.HKO2025-11-04
04560126269140AUTO KERATO-REFRACTOMETER KR-800TOPCON CORPORATIONHKO2025-10-31
04560126269164AUTO REFRACTOMETER RM-800TOPCON CORPORATIONHKO2025-10-31
B43050085600GoCheck KidsGobiquity, Inc.HKO2025-10-22
00860014277528S4Optik REF-K2000Lombart Brothers, Inc.HKO2025-10-18
04540008310030RexxamREXXAM CO., LTD.HKO2025-10-17
04540008310320RexxamREXXAM CO., LTD.HKO2025-10-17
04540008310436RexxamREXXAM CO., LTD.HKO2025-10-17
04540008310443RexxamREXXAM CO., LTD.HKO2025-10-17
04540008310603RexxamREXXAM CO., LTD.HKO2025-10-17
07350023774307CalcibonBiomet Biologics, LLCHKX2025-10-09
06973211071869Kerato refractometerCHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTDHKO2025-08-18
06973211071876Kerato refractometerCHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTDHKO2025-08-18