TOPCON 42-0002770

GUDID 08034028770524

SOLOS Lite is an instrument intended for use by an optometric/ ophthalmic professional to monitor the visual defects through the measurements of spectacles and single lens optical properties

VISIA IMAGING SRL

Automated lensmeter

• Primary Device ID: 08034028770524
• NIH Device Record Key: 312332a2-eb30-4bd5-a654-7d2dc3bf93f2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TOPCON
• Version Model Number: SOLOS LITE
• Catalog Number: 42-0002770
• Company DUNS: 447668039
• Company Name: VISIA IMAGING SRL
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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	08034028770524 [Primary]

FDA Product Code

• HLM: Instrument, Measuring, Lens, 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: 2025-02-28
• Device Publish Date: 2025-02-20

On-Brand Devices [TOPCON]

• 08034028770562: instrument intended for use by an optometric/ ophthalmic professional for the analysis of visual
• 08034028770524: SOLOS Lite is an instrument intended for use by an optometric/ ophthalmic professional to monito