TOPCON

Basic Information

• Brand Name: TOPCON
• Primary DI: 08034028770524
• Version / Model: SOLOS LITE
• Catalog Number: 42-0002770
• Company Name: VISIA IMAGING SRL
• Labeler DUNS: 447668039
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-02-20
• Public Version: 1
• Public Version Date: 2025-02-28
• Public Version Status: New
• Public Device Record Key: 312332a2-eb30-4bd5-a654-7d2dc3bf93f2

Device Description

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

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HLM	Instrument, Measuring, Lens, Ac-Powered	Ophthalmic	886.1425	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45753	Automated lensmeter	A mains electricity (AC-powered) ophthalmic instrument designed to measure the focusing power (dioptric power) and other optical characteristics of a spectacle lens, contact lens, or prism. The device is fully automated and does not require manual adjustments of its measurement systems. It provides the operator with automatic readings on an integral screen, and will typically record and print-out the results.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08034028770524	GS1