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wavelight fs200 patient interface
Alcon Laboratories
Summary: The Wavelight FS200 patient interface is a femtosecond laser device used primarily in LASIK procedures. Key evidence highlights its role in flap creation with reported outcomes and safety profiles.
FDA Clearance Information
Pathway
510K
Number
K190392 ↗
Decision Date
March 26, 2019
Product Code
GEX
Device Class
Class 2
Evidence
0 studies
The Wavelight FS200 patient interface was cleared via the FDA 510(k) pathway on March 26, 2019. It is manufactured by Alcon Laboratories and classified as a Class 2 device.
What It Is
The Wavelight FS200 is a femtosecond laser device designed for creating corneal flaps in LASIK surgery. It utilizes precise laser pulses to separate corneal tissue, facilitating refractive correction.
Clinical Applications
Commonly used in LASIK procedures, the Wavelight FS200 aids in creating consistent and predictable corneal flaps. It is employed in refractive surgeries to correct vision by reshaping the cornea.
Evidence Summary
The available literature includes a mix of RCTs, prospective, and retrospective studies, totaling 8 publications from 2013 to 2025. These studies evaluate the device's efficacy and safety in LASIK procedures.
Reported Outcomes
Published studies report that the Wavelight FS200 provides predictable flap thickness and morphology in LASIK procedures. It has been shown to effectively assist in corneal pocket and tunnel implantations for keratoconus management.
Safety Profile
Reported complications include unilateral rainbow glare and interface blood as indications for flap lift. These events highlight the importance of careful patient selection and surgical technique.
Evidence Limitations
Current evidence is limited by the small number of studies directly comparing the Wavelight FS200 with other devices. Further research is needed to establish long-term outcomes and safety profiles.
Frequently Asked Questions
What are the clinical indications for Wavelight FS200 patient interface?
The Wavelight FS200 is indicated for use in LASIK procedures to create corneal flaps and in corneal pocket and tunnel implantations for keratoconus management.
What outcomes have been reported in clinical studies?
Studies report predictable flap thickness and morphology, as well as effective outcomes in keratoconus management using the Wavelight FS200.
What complications have been reported?
Safety data indicate complications such as unilateral rainbow glare and interface blood, which may necessitate flap lift procedures.
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.