Visionix

GUDID 03664188000015

ophthalmic slit lamp

LUNEAU TECHNOLOGY OPERATIONS

Ophthalmic examination slit lamp

• Primary Device ID: 03664188000015
• NIH Device Record Key: 02a178d4-003c-4d58-9579-ae0bde9c5cdc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Visionix
• Version Model Number: VX70 5x
• Company DUNS: 260432380
• Company Name: LUNEAU TECHNOLOGY OPERATIONS
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	03664188000015 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082031

FDA Product Code

• HJO: Biomicroscope, Slit-Lamp, Ac-Powered

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-16
• Device Publish Date: 2023-06-08

On-Brand Devices [Visionix]

• 03664188002200: The VX220 is a multifunctional eye diagnostic device. There are several operation modes combined
• 03664188000886: ophthalmic slit lamp
• 03664188000879: ophthalmic slit lamp
• 03664188000862: ophthalmic slit lamp
• 03664188000855: ophthalmic slit lamp
• 03664188000831: ophthalmic slit lamp
• 03664188000824: ophthalmic slit lamp
• 03664188000817: ophthalmic slit lamp
• 03664188000800: ophthalmic slit lamp
• 03664188000787: ophthalmic slit lamp
• 03664188000770: ophthalmic slit lamp
• 03664188000763: ophthalmic slit lamp
• 03664188000756: ophthalmic slit lamp
• 03664188000909: The VX130 is a multi-function diagnostic device combining wavefront aberometer, corneal topograp
• 03664188000046: The VX120+ is a multi-function diagnostic device combining corneal topographer, retro-illuminato
• 03664188000039: The VX130+ is a multifunctional eye diagnostic device. There are several operation modes combine
• 03664188000541: VX40 APS
• 03664188000466: Prism Bar vertical
• 03664188000459: Prism Bar horizontal
• 03664188000442: Prism Bar Set horiz./vertical
• 03664188000404: VX610
• 03664188000398: PRISM BARS SET (HORIZ. + VERT) + 2 add prisms 40 a
• 03664188000381: Nexy
• 03664188000329: VX40
• 03664188000251: Chart Display
• 03664188000244: Chart Display
• 03664188000237: Chart Display
• 03664188000220: Skiascopy racks
• 03664188000176: Chart Display
• 03664188000152: Chart Display
• 03664188000091: ophthalmic slit lamp
• 03664188000060: The VX120+ is a multi-function diagnostic device combining corneal topographer, retro-illuminato
• 03664188000015: ophthalmic slit lamp
• 03664188000008: ophthalmic slit lamp
• 03664188000084: EyeRefract
• 03664188000411: VX610
• 03664188000169: VX90 is an ophthalmic diagnostic device, autorefracto-keratometer
• 03664188000077: The VX65 is an automatic phoropter, to measure the subjective refraction, it is used as an ophth
• 03664188000602: VX40 Pro