Duns Number:690635461
Device Description: The NIDEK AUTO LENSMETER LM-1800P/LM-1800PD measures the optical performance of spectacle The NIDEK AUTO LENSMETER LM-1800P/LM-1800PD measures the optical performance of spectacle lenses such as single vision, bifocal (trifocal), and progressive power lenses or contact lenses. This device has a measuring unit and a display unit in front, and a printer unit on the right side.
Catalog Number
-
Brand Name
AUTO LENSMETER
Version/Model Number
LM-1800P
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
2b7b3e3d-c679-418e-bb6f-e59040f0940a
Public Version Date
May 21, 2018
Public Version Number
1
DI Record Publish Date
April 20, 2018
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 |