Identity
- Trade Name
- VISULAS Trion FDA UDI
- Generic Name
- Ophthalmic solid-state laser system FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- VISULAS Trion, VISULAS Trion VITE FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04049471091229 FDA UDI
- FDA Product Code
- GEX FDA UDIHQF FDA UDI
- GMDN Term
- Ophthalmic solid-state laser system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4810 FDA UDI886.4390 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Ophthalmic solid-state laser system
VISULAS Trion by Carl Zeiss Meditec AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ophthalmic solid-state laser system.
- Eagle — Belkin Vision, Ltd. · Class II
- Integre Pro Scan Red-Green — ELLEX MEDICAL PTY LTD · Class II
- Ellex — ELLEX MEDICAL PTY LTD · Class II
- EASYRET — QUANTEL MEDICAL · Class II
- 25ga Straight Laser Probe — Vortex Surgical, Inc. · Class II
- Voyager DSLT — Belkin Vision, Ltd. · Class II
- TruScan Pro — Lightmed Corp. · Class II
- Smart-V Illumination Add-on — Lumenis Be, Inc. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Carl Zeiss Meditec AG
Sources (1)
- FDA UDI 676df2a6-a03b-4578-89dd-c4792bf48e3d 36 fields · synced Jun 8, 2026