Duns Number:690635461
Device Description: The RT-6100 is a motorized refractor for subjective refraction designed to be connected wi The RT-6100 is a motorized refractor for subjective refraction designed to be connected with other Nidek products such as the Auto Refractometer and/or Lensmeter to import their measurement data. Measurement of refractive errors (spherical power, cylindrical power, and cylinder axis) and binocular visual function testing are performed according to the patient’s response.
Catalog Number
-
Brand Name
REFRACTOR
Version/Model Number
RT-6100
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 29, 2019
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
HKN
Product Code Name
Refractor, Manual, Non-Powered, Including Phoropter
Public Device Record Key
8faf4599-8c2d-4b02-9e89-dca0c2ef7843
Public Version Date
December 21, 2020
Public Version Number
3
DI Record Publish Date
March 26, 2019
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 |