Duns Number:447668039
Device Description: instrument intended for use by an optometric/ ophthalmic professional to measure spectacle instrument intended for use by an optometric/ ophthalmic professional to measure spectacles and single lens properties.
Catalog Number
42-0001417
Brand Name
TOPCON
Version/Model Number
SOLOS
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
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)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HLM
Product Code Name
Instrument, Measuring, Lens, Ac-Powered
Public Device Record Key
dcfa266c-66d6-496e-835d-2ac9d7b6899b
Public Version Date
September 23, 2022
Public Version Number
1
DI Record Publish Date
September 15, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |