FDA.reportPublic FDA data

ESSILOR

Primary DI
03664188000565
Brand
ESSILOR
Company
LUNEAU TECHNOLOGY OPERATIONS
Model
WAM 800
Device description
WAM800 is a multifunctional eye diagnostic device.
Published
2025-01-02
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03664188000565PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03664188000565036641880005653664188000565

GMDN Terms#

Term, Definition table
TermDefinition
Multiple ocular dimension meterAn electrically-powered, ophthalmic device intended to measure multiple dimensional parameters of the eye (e.g., refractive error, corneal anterior surface curvature/thickness, distance between pupils) during an ophthalmic examination, typically to determine a patient's prescription for glasses or evaluate the need for surgery; it not dedicated to measurement of a single dimensional parameter (i.e., it is not a refractometry-, keratometry-, pachymetry-, pupillometry-, or topography-only device). It may be a hand-held or tabletop device, and may be designed for connection to an off-the-shelf computer for device control and/or results analysis/display.

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
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
03664188000244VisionixVX22-LP2023-06-08

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