Duns Number:314594680
Device Description: VISULAS green is intended for use in photocoagulation of tissues in the posterior and ante VISULAS green is intended for use in photocoagulation of tissues in the posterior and anterior segments of the eye including trabeculoplasty and iridotomy.The DI number characterizes the laser slit lamp LSL green classic. This laser slit lamp forms part of the model VISULAS green classic.
Catalog Number
-
Brand Name
VISULAS green
Version/Model Number
VISULAS green
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K181682
Product Code
HQF
Product Code Name
Laser, Ophthalmic
Public Device Record Key
4291be49-2682-4427-a470-d5805baad645
Public Version Date
November 10, 2021
Public Version Number
3
DI Record Publish Date
May 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 | 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 |