📊 Evidence-Based Reference

elita femtosecond laser system elita patient interface

Johnson & Johnson Surgical Vision

Summary: The elita femtosecond laser system by Johnson & Johnson is used for refractive eye surgery, specifically for procedures like Smooth Incision Lenticular Keratomileusis (SILK). Key evidence highlights its effectiveness in correcting myopic refractive errors.

FDA Clearance Information

Pathway 510K
Decision Date April 14, 2023
Product Code OOE
Device Class Class 2
Evidence 0 studies

The elita femtosecond laser system was cleared through the FDA 510(k) pathway on April 14, 2023. It is manufactured by Johnson & Johnson Surgical Vision and is classified as a Class 2 device.

What It Is

The elita femtosecond laser system is a precision laser device designed for refractive eye surgery. It is primarily used for creating corneal incisions and lenticule extraction in procedures like SILK, aimed at correcting myopic refractive errors.

Clinical Applications

Commonly used in ophthalmology, the elita femtosecond laser system is applied in procedures to correct myopia and astigmatism. It is particularly useful in creating precise corneal incisions and lenticule extractions.

Evidence Summary

The available literature includes 8 studies, primarily focusing on the safety and effectiveness of the elita femtosecond laser system in refractive surgery. These studies range from prospective trials to retrospective analyses, conducted around 2024.

Reported Outcomes

Published studies report that the elita femtosecond laser system is effective in correcting myopic refractive errors, with improvements in visual acuity noted post-procedure. The system's precision in creating corneal incisions contributes to favorable refractive outcomes.

Safety Profile

Reported complications include changes in corneal tissue structure and higher-order aberrations. However, the overall safety profile is consistent with other femtosecond laser systems used in refractive surgery.

Evidence Limitations

The evidence is limited by the lack of long-term follow-up data and the need for larger sample sizes to confirm findings. Further research is needed to explore the full range of potential complications and long-term outcomes.

Frequently Asked Questions

What are the clinical indications for elita femtosecond laser system?

The elita femtosecond laser system is indicated for use in refractive surgeries, specifically for correcting myopic refractive errors and astigmatism through procedures like Smooth Incision Lenticular Keratomileusis (SILK).

What outcomes have been reported in clinical studies?

Clinical studies have reported improvements in visual acuity and effective correction of myopic refractive errors following the use of the elita femtosecond laser system.

What complications have been reported?

Reported complications include changes in corneal tissue structure and higher-order aberrations, though these are consistent with other similar laser systems.

Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference. It does not constitute medical advice, product endorsement, or a recommendation for clinical use. Always consult manufacturer documentation and clinical judgment for patient care decisions.

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