MYOPIA EXPERT 700 BMT00004

GUDID 08034028770463

BIOMETER - TOPOGRAPHER

VISIA IMAGING SRL

Corneal topography system Corneal topography system Corneal topography system Corneal topography system Corneal topography system Corneal topography system

• Primary Device ID: 08034028770463
• NIH Device Record Key: 341087e5-27ce-4e42-8d0b-760a15c62660
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MYOPIA EXPERT 700
• Version Model Number: MYOPIA EXPERT 700
• Catalog Number: BMT00004
• Company DUNS: 447668039
• Company Name: VISIA IMAGING SRL
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08034028770463 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211868

FDA Product Code

• MXK: Device, Analysis, Anterior Segment

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: 2022-06-30
• Device Publish Date: 2022-06-22

Devices Manufactured by VISIA IMAGING SRL

• 08034028770487 - MYAH: 2023-10-20
• 08034028770470 - SeeNA: 2023-06-05 INTEGRATED DEVICE OCULAR BIOMETER AND CORNEAL ANALYZER
• 08034028770463 - MYOPIA EXPERT 700: 2022-06-30BIOMETER - TOPOGRAPHER
• 08034028770463 - MYOPIA EXPERT 700: 2022-06-30 BIOMETER - TOPOGRAPHER
• 08034028770456 - MYAH: 2022-06-22
• 08034028770364 - ALADDIN-M: 2020-09-17