Johnson & Johnson Vision Receives FDA Clearance for its Elita Femtosecond Laser

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

Features of the Elita include:

• Confidence, speed and accuracy, through:
  • Low energy per pulse, combined with ultra-fast laser repetition rate and small spot size (1µm)[1,2,3]
  • Smooth stromal bed, allowing for effortless flap lifts[1,3]
  • Industry leading laser performance with sub-micron precision[3]
• Exceptional ease and efficiency for practices, with an intuitive user interface, modular design, and a quick system startup in less than 5 minutes[4]
• Better outcomes for patients, with features designed to reduce complications, improve visual outcomes, and enable fast visual recovery[3]

“For the last two decades, Johnson & Johnson Vision has been a leader in the industry in precision, personalization and proven exceptional outcomes in laser correction,” said Xiao-Yu Song, Global Head of R&D, Johnson & Johnson Vision. “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 will be available to ophthalmologists across the United States later this year.

References

[1] ASCRS 2022 LASIK Flap Accuracy Comparison Between A New Femtosecond Laser and iFS, Mahipal Sachdev

[2] DOF2023OTH4002: The ELITA™ Femtosecond Platform Patient Interface Design

[3] DOF2023RF4002: The ELITA™ Femtosecond Laser device description

[4] 0155-1910 ELITA operator's manual (Flap) US edition (v0.2) REF2023RF4014

[5] Sarayba, Melvin A MD*; Ignacio, Teresa S MD*†; Binder, Perry S MS, MD*‡; Tran, Dan B MD§. Comparative Study of Stromal Bed Quality by Using Mechanical, IntraLase Femtosecond Laser 15- and 30-kHz Microkeratomes. Cornea 26(4):p 446-451, May 2007