Duns Number:690635461
Device Description: The TS-310 is a space-saving automated refraction system that uses a combination of the re The TS-310 is a space-saving automated refraction system that uses a combination of the refractor head of the RT-3100 and a control box.• With the high precision LCD, visual acuity of 5 m as well as near visual acuity of 40 cm can be measured with the same accuracy as a standard refraction using actual distances.• The objective data measured by a NIDEK auto refractometer and the lensometry data measured by a NIDEK lensmeter can be imported and used in this device.
Catalog Number
-
Brand Name
Tabletop Refraction System
Version/Model Number
TS-310
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"
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For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HKN
Product Code Name
Refractor, Manual, Non-Powered, Including Phoropter
Public Device Record Key
72070dac-f207-4ffa-9003-4a08042692a5
Public Version Date
December 21, 2020
Public Version Number
4
DI Record Publish Date
July 03, 2017
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 | 39 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 73 |
| 3 | A medical device with high risk that requires premarket approval | 5 |