FDA.reportPublic FDA data

Visionix

Primary DI
03664188000466
Brand
Visionix
Company
LUNEAU TECHNOLOGY OPERATIONS
Model
Prism Bar vertical
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
HKWPrism, Bar, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HKWPrism, Bar, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03664188000466PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03664188000466036641880004663664188000466

GMDN Terms#

Term, Definition table
TermDefinition
Diagnostic ophthalmic prismA transparent geometrical device intended to use light refraction principles to assist in the diagnosis of visual problems, especially those associated with ocular muscles (e.g., reduced convergence or accommodation). It is available in various forms such as a bar with multiple prisms of graduated powers, or a single prism on a handle. This is a reusable device.

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
03664188000220VisionixL2 Skiascopy racks2023-06-08
03664188000237VisionixVX22-NP2023-06-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00360843010469OptegoOptego Vision USA Inc.HKW2023-11-03
00360843010476OptegoOptego Vision USA Inc.HKW2023-11-03
00360843010483OptegoOptego Vision USA Inc.HKW2023-11-03
00360843010490OptegoOptego Vision USA Inc.HKW2023-11-03
00360843010506OptegoOptego Vision USA Inc.HKW2023-11-03
00360843010513OptegoOptego Vision USA Inc.HKW2023-11-03
00360843010520OptegoOptego Vision USA Inc.HKW2023-11-03
00360843010537OptegoOptego Vision USA Inc.HKW2023-11-03
00360843010544OptegoOptego Vision USA Inc.HKW2023-11-03
00360843010551OptegoOptego Vision USA Inc.HKW2023-11-03
00360843010568OptegoOptego Vision USA Inc.HKW2023-11-03
00360843010575OptegoOptego Vision USA Inc.HKW2023-11-03
00360843010582OptegoOptego Vision USA Inc.HKW2023-11-03
00360843010599OptegoOptego Vision USA Inc.HKW2023-11-03
00360843010605OptegoOptego Vision USA Inc.HKW2023-11-03
00360843010612OptegoOptego Vision USA Inc.HKW2023-11-03
00360843010629OptegoOptego Vision USA Inc.HKW2023-11-03
00360843010636OptegoOptego Vision USA Inc.HKW2023-11-03
00360843010643OptegoOptego Vision USA Inc.HKW2023-11-03
00360843010650OptegoOptego Vision USA Inc.HKW2023-11-03
00360843010667OptegoOptego Vision USA Inc.HKW2023-11-03
00360843010674OptegoOptego Vision USA Inc.HKW2023-11-03
00360843010681OptegoOptego Vision USA Inc.HKW2023-11-03
00360843010230OptegoOptego Vision USA Inc.HKW2023-11-01
00360843010247OptegoOptego Vision USA Inc.HKW2023-11-01
00360843010254OptegoOptego Vision USA Inc.HKW2023-11-01
00360843010261OptegoOptego Vision USA Inc.HKW2023-11-01
00360843010278OptegoOptego Vision USA Inc.HKW2023-11-01
00360843010285OptegoOptego Vision USA Inc.HKW2023-11-01
00360843010292OptegoOptego Vision USA Inc.HKW2023-11-01