Duns Number:314594680
Device Description: The VISULAS 532s Laser System with the VITE option is intended for use in retinal, panreti The VISULAS 532s Laser System with the VITE option is intended for use in retinal, panretinal, focal and grid photocoagulation of ocular tissues in the treatment of diseases of the eye including:* Proliferative and nonproliferative diabetic retinopathy* Macular edema* Branch and central retinal vein occlusion* Lattice degeneration* Retinal tears and detachments
Catalog Number
-
Brand Name
VISULAS 532s
Version/Model Number
VISULAS 532s, VISULAS 532s VITE
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
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Prescription Use (Rx)
-
Over the Counter (OTC)
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Kit
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Combination Product
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Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K013402,K100035
Product Code
GEX
Product Code Name
Powered Laser Surgical Instrument
Public Device Record Key
703e809a-df0e-44b7-9563-24aeb4ec912a
Public Version Date
November 10, 2021
Public Version Number
5
DI Record Publish Date
September 20, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 14 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 86 |
| 3 | A medical device with high risk that requires premarket approval | 1 |