ESSILOR BMT00004

GUDID 08034028770517

BIOMETER - TOPOGRAPHER

VISIA IMAGING SRL

Corneal topography system

• Primary Device ID: 08034028770517
• NIH Device Record Key: 9facdf7a-3d67-4bb5-853b-66c66d52db86
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ESSILOR
• 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	08034028770517 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222933

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: 2024-11-12
• Device Publish Date: 2024-11-04

Devices Manufactured by VISIA IMAGING SRL

• 08034028770609 - TERA Dry Eye Imager: 2025-08-14
• 08034028770524 - TOPCON: 2025-02-28 SOLOS Lite is an instrument intended for use by an optometric/ ophthalmic professional to monitor the visual defects through the
• 08034028770562 - TOPCON: 2025-02-28 instrument intended for use by an optometric/ ophthalmic professional for the analysis of visual acuity
• 08034028770517 - ESSILOR: 2024-11-12BIOMETER - TOPOGRAPHER
• 08034028770517 - ESSILOR: 2024-11-12 BIOMETER - TOPOGRAPHER
• 08034028770487 - MYAH: 2023-10-20
• 08034028770470 - SeeNA: 2023-06-05 INTEGRATED DEVICE OCULAR BIOMETER AND CORNEAL ANALYZER
• 08034028770463 - MYOPIA EXPERT 700: 2022-06-30 BIOMETER - TOPOGRAPHER
• 08034028770456 - MYAH: 2022-06-22