Victus Femtosecond Laser Platform
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- VICTUS Femtosecond Laser Platform EUDAMED
- Device Name
- VICTUS Femtosecond Laser Platform EUDAMED
- Model / Reference
- 15000TPV EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04050555728986 EUDAMED
- Basic UDI-DI
- B-04050555728986 EUDAMED
- 510(k) Number
- K151161 FDA 510(k)
- FDA Product Code
- OOE FDA 510(k)
- EMDN Code
- Z12011006 DIODE–PUMPED SOLID–STATE (DPSS) SURGICAL LASER EUDAMED
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 886.4390 FDA 510(k)
- Regulation Number
- 886.4390 FDA 510(k)
- Market of Registration
- Germany EUDAMED
- Advisory Committee
- Ophthalmic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
The Victus Femtosecond Laser Platform is an ophthalmic femtosecond laser designed for precision laser-assisted eye surgery. It employs ultra-short laser pulses to perform intricate procedures such as cataract surgery, corneal flap creation for LASIK, and other refractive or therapeutic interventions with high accuracy and minimal invasiveness.
This device is supplied as a reusable, integrated surgical platform intended for use in sterile operating environments. It is classified as a Class II medical device under FDA regulations and has received FDA 510(k) clearance and MDD authorization. The platform is engineered for versatility, supporting multiple ophthalmic procedures, and is regulated under the European Medical Device Directive (MDD) and FDA requirements for ophthalmic devices.
Frequently asked questions
What types of ophthalmic procedures is the Victus Femtosecond Laser Platform designed to assist with, and how does it achieve precision in these surgeries?
The Victus Femtosecond Laser Platform is designed for precision laser-assisted eye surgeries, including cataract surgery and corneal flap creation for LASIK. It uses ultra-short laser pulses to perform intricate procedures with high accuracy and minimal invasiveness, ensuring controlled tissue interaction for better surgical outcomes.
Is the Victus Femtosecond Laser Platform a single-use or reusable device, and how should it be maintained in a sterile operating environment?
The Victus Femtosecond Laser Platform is a reusable, integrated surgical platform. Since it is intended for sterile operating environments, it must be properly cleaned, disinfected, and maintained according to manufacturer guidelines to ensure sterility and functionality between uses.
What regulatory pathways has the Victus Femtosecond Laser Platform followed, and what does this mean for its use in clinical settings?
The Victus Femtosecond Laser Platform has received FDA 510(k) clearance and MDD authorization, confirming it meets regulatory standards for ophthalmic devices in the U.S. and Europe. This means it has been evaluated for safety and effectiveness, allowing clinicians to use it with confidence in approved procedures like cataract surgery and LASIK.
Are there different models or configurations available for the Victus Femtosecond Laser Platform, and how might this affect procedure selection?
The Victus Femtosecond Laser Platform supports multiple ophthalmic procedures, but the provided data does not specify distinct models or configurations. However, its versatility suggests it is engineered to adapt to various surgical needs, such as refractive or therapeutic interventions, without requiring additional hardware.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Victus Femtosecond Laser Platform | Bausch + Lomb Surgical, VICTUS™ Femtosecond Laser Platform - Technolas PV, VICTUS - Bausch Surgical
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K151161 | Class II | Active |
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Manufacturer
- Manufacturer
- Technolas Perfect Vision GmbH
Sources (2)
- FDA 510(k) K151161 24 fields · synced Sep 18, 2026
- EUDAMED 5fa3d3c1-d17b-4535-9f0c-de8d3ccdee0b 61 fields · synced Jul 24, 2026