Duns Number:277373213
Device Description: The WAM700 is a multifunctional ophthalmic device. The machine is a combination of 5 techn The WAM700 is a multifunctional ophthalmic device. The machine is a combination of 5 technologies :- Shack Hartmann technology : to measure both low and high order aberrations of the eye, to measure refraction.- Placido disks : for keratometry and for corneal topography measurement.- Non-contact tonometer.- Scheimpflug image : for anterior chamber analysis (pachymetry, irido corneal angle).- Retro illumination : for detection of opacity.Measurement is fully automatic using image processing software and fully automated motors for centering and focusing. The machine includes a fixation target with automatic fogging for accommodation control.
Catalog Number
-
Brand Name
WAVE ANALYZER MEDICA 700
Version/Model Number
WAM700
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HKX
Product Code Name
Tonometer, Ac-Powered
Public Device Record Key
5045f179-a735-42b0-b255-f9c1ae2f1c40
Public Version Date
December 21, 2020
Public Version Number
5
DI Record Publish Date
September 23, 2016
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 15 |