FDA Grants 510(k) Clearance for the ELITA Femtosecond Laser

 FDA Grants 510(k) Clearance for the ELITA Femtosecond Laser

Johnson & Johnson Vision has announced that its new ELITA Femtosecond Laser has received FDA 510(k) clearance for the creation of LASIK flaps. ELITA was recently unveiled at the 2023 American Society of Cataract and Refractive Surgery Annual Meeting in San Diego, May 5-8.

“For the last two decades, Johnson & Johnson Vision has been a leader of the industry in precision, personalization and proven exceptional outcomes in laser correction,” said Xiao-Yu Song, Global Head of R&D, Johnson & Johnson Vision.

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“Today, we’re excited to announce that we’re building on that legacy with our ELITA Femtosecond Laser, which offers a generational leap in corneal refractive technology, with benefits for surgeons, practices and patients alike.”

The ELITA Femtosecond laser flap innovation delivers:

  • Empowering surgeons with confidence, speed and accuracy, through:
    • Low energy per pulse, combined with ultra-fast laser repetition rate and small spot size (1µm)
    • Smooth stromal bed, allowing for effortless flap lifts
    • Industry leading laser performance with sub-micron precision
  • Exceptional ease and efficiency for practices, with an intuitive user interface, modular design, and a quick system startup in less than 5 minutes
  • Better outcomes for patients, with features designed to reduce complications, improve visual outcomes, and enable fast visual recovery.

The ELITA Femtosecond Laser will be available to ophthalmologists across the U.S. later this year.

Read the full press release from Johnson & Johnson Vision.

Source: Johnson & Johnson Vision

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