SeeNA SEENA006100

GUDID 08034028770470

INTEGRATED DEVICE OCULAR BIOMETER AND CORNEAL ANALYZER

VISIA IMAGING SRL

Corneal topography system analyser

• Primary Device ID: 08034028770470
• NIH Device Record Key: 64eae82e-3bb5-4bd3-b223-c9c087bb9ac8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SeeNA
• Version Model Number: SeeNA
• Catalog Number: SEENA006100
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08034028770470 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160327

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: 2023-06-05
• Device Publish Date: 2023-05-26

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: 2024-11-12 BIOMETER - TOPOGRAPHER
• 08034028770487 - MYAH: 2023-10-20
• 08034028770470 - SeeNA: 2023-06-05INTEGRATED DEVICE OCULAR BIOMETER AND CORNEAL ANALYZER
• 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