Duns Number:654386890
Device Description: TL-6800 Auto lensmeterHartmann sensor with 145 measurement points, ensures better result f TL-6800 Auto lensmeterHartmann sensor with 145 measurement points, ensures better result for progressive and multi-focus recognition and more accurate resultsGreen spectral measurement light sourceHigher level hardware, good tracing performance of the optical system and faster measurement speedCan measure lens of low transmittance rate no less than 5% , sun glasses with dark color, tinted lens and polarized lensUV measurementHumanized design, tiltable screen, comfortable operation and easier for observationData can be transferred to auto phoropter
Catalog Number
-
Brand Name
AUTO LENSMETER
Version/Model Number
TL-6800
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
16348550-73ae-480e-9cf9-46f2be3bdd2c
Public Version Date
December 10, 2019
Public Version Number
1
DI Record Publish Date
December 02, 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 | 15 |