Duns Number:545824560
Device Description: It is mainly used to measure the vertex power and prism power of various spectacle lenses, It is mainly used to measure the vertex power and prism power of various spectacle lenses, determine the position and direction of the column lens axis, print marks on the unprocessed lens, and check whether the lens are correctly installed in the frame
Catalog Number
-
Brand Name
Lensmeter
Version/Model Number
SK-1000A
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)
-
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
52745e92-13b1-40a7-be21-a8778ba8c9b7
Public Version Date
July 10, 2020
Public Version Number
1
DI Record Publish Date
July 02, 2020
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 | 9 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 20 |