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Zeiss earns FDA 510k clearance for the Visulas yag laser

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3 min read

ZEISS Medical Technology has received 510(k) clearance from the FDA for its ZEISS VISULAS yag laser, designed for posterior capsulotomy and iridotomy procedures.

Let’s talk about this laser.

The VISULAS is intended for safe and effective photodisruption by enabling surgeons to perform posterior capsulotomy for a number of different intraocular lenses (IOLs) and iridotomy.

Per ZEISS, the laser workstation is designed as "modern and compact."

Other versions of this therapeutic laser include:

Photocoagulation

Combi

Photodisruption

Give me some details.

Per Zeiss, the VISULAS is a Class 4, flash lamp-pumped and Q-switched Nd: YAG laser.

  • Laser wavelength of therapy beam = 1064 nm
  • Pulse duration = < 4 ns (typically 2 to 3 ns)
  • Pulse modes
    • Single pulse: 9.0 mJ to 13.0 mJ at max. 2.5 Hz
    • Double pulse: 18.0 mJ to 28.0 mJ at max 1.0 Hz
    • Triple pulse: 29.0 mJ to 45.0 mJ at max 1.0 Hz

See here for additional technical data.

And its capabilities?

Per ZEISS, the application-based laser offers the following:

  • High-precision treatment
    • A super gaussian laser beam profile targets an optimal, minimal amount of laser energy for the treatment point.
  • Motorized focus shift adjustment
    • Based on a selected application, this sets the treatment beam’s focal point (in front, behind, or directly at the beam).
  • Accurate focusing for a high variety of IOL conditions
    • Based on a 4-point aiming bea system, this merges into one at the laser focal plane for high-precision focusing
    • To note, if implanting a multifocal IOL, a 2-point aiming beam is possible.
  • Precise capsulotomy laser for cataract workflow
    • The workstation can be connected to the ZEISS FORUM—an ophthalmic data management solution—integrated into the company’s ZEISS Cataract Workflow, giving a clinician the option to treat posterior capsulotomy opacification.

Well, now you need to explain this cataract workflow.

The ZEISS Cataract Workflow is a digital, integrable process for cataract surgery that utilizes the ZEISS product portfolio to allow surgeons to operate more efficiently and enable a direct display of diagnostic data and treatment reports at their workstations (via the ZEISS Forum).

Click here to learn more.

To note, the company currently offers seven different workflows. See them all here.

And the ZEISS Forum?

By connecting to the system, the laser therapy can be integrated into a surgeon's clinical workflow and enable them to access and review patients’ data before an exam, treatment, or follow-up.

Lastly … where can I find it?

Go here to contact ZEISS about purchasing the laser.

And if you’re attending the American Academy of Ophthalmology (AAO) annual meeting in San Francisco, California, next week (November 4-6, 2023), stop by the ZEISS booth (#2321) for a demonstration!


*Featured image property of ZEISS Medical Technology.

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