VISULAS Trion - The VISULAS Trion Laser System is intended for - Carl Zeiss Meditec AG

Duns Number:314594680

Device Description: The VISULAS Trion Laser System is intended for use in single-spot laser photocoagulation o The VISULAS Trion Laser System is intended for use in single-spot laser photocoagulation of ocular tissues for the treatment of diseases of the eye, such as:* Photocoagulation of the retina* Trabeculoplasty for treatment of glaucoma* Iridotomy for treatment of glaucoma.The VISULAS Trion Laser System with the VITE option is intended for use in multispot 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* Choroidal neovascularization associated with wet age-related macular degeneration.

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More Product Details

Catalog Number

-

Brand Name

VISULAS Trion

Version/Model Number

VISULAS Trion, VISULAS Trion VITE

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K072514,K103056

Product Code Details

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Device Record Status

Public Device Record Key

676df2a6-a03b-4578-89dd-c4792bf48e3d

Public Version Date

November 10, 2021

Public Version Number

5

DI Record Publish Date

September 20, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CARL ZEISS MEDITEC AG" Characteristics
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