FDA.reportPublic FDA data

Visionix

Primary DI
03664188000220
Brand
Visionix
Company
LUNEAU TECHNOLOGY OPERATIONS
Model
L2 Skiascopy racks
Device description
Skiascopy racks
Published
2023-06-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HMHRack, Skiascopic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HMHRack, SkiascopicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03664188000220PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03664188000220036641880002203664188000220

GMDN Terms#

Term, Definition table
TermDefinition
Trial lens setA set of ophthalmic trial lenses of various dioptric powers intended for vision testing to determine the required refraction. This device typically includes other related devices such as a trial frame into which the trial lenses can be rapidly exchanged during the examination.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
260432380
Device count
1
Premarket exempt
true
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
03664188000237VisionixVX22-NP2023-06-08
03664188000244VisionixVX22-LP2023-06-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B945TOM1800BernellBernellHMH2026-05-03
B945CBAR40BernellBernellHMH2026-05-02
B945DSLRS80BernellBernellHMH2026-05-02
B945HTLRPS0BernellBernellHMH2026-05-02
B945L1220840BernellBernellHMH2026-05-02
B091151600Retinoscopy Rack with CompassGulden Ophthalmics Inc.HMH2023-07-05
B091151610Retinoscopy RackGulden Ophthalmics Inc.HMH2023-07-05
06945033901211TIANNUO / TNMEDLianyungang Tiannuo Optical Instrument Co., Ltd.HMH2018-09-24
06945033901235TIANNUO / TNMEDLianyungang Tiannuo Optical Instrument Co., Ltd.HMH2018-09-24