AccessGUDID - DEVICE: TOPCON (08034028770524)

GUDID

Device Identifier (DI) Information

Brand Name: TOPCON
Version or Model: SOLOS LITE
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 42-0002770
Company Name: VISIA IMAGING SRL

Primary DI Number: 08034028770524
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 447668039 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HLM	Instrument, Measuring, Lens, Ac-Powered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 312332a2-eb30-4bd5-a654-7d2dc3bf93f2
Public Version Date: February 28, 2025
Public Version Number: 1
DI Record Publish Date: February 20, 2025