đź“Š Evidence-Based Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Use with the Wavelight FS200 femtosecond laser system for ophthalmic procedures as specified in the cleared labeling.
- Support femtosecond-laser creation of corneal flaps in patients undergoing LASIK or other labeled corneal refractive procedures.
Clinical Applications
- Patient-eye coupling during Wavelight FS200 femtosecond laser treatment
- Creation of corneal flaps for LASIK
- Use during laser-assisted corneal refractive surgery when the interface is compatible with the Wavelight FS200 system and used according to its instructions
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.
Practical Considerations
- This is an ophthalmic patient interface, not an implantable device or a standalone laser system.
- Compatibility is limited to the specified Wavelight FS200 femtosecond laser system and associated accessories; clinicians should verify the exact model and labeling before use.
- The interface is used on the eye and requires appropriate patient selection, sterile or aseptic handling, and proper positioning and suction according to the manufacturer’s instructions.
- It is generally a single-use component; it should not be reused unless the FDA-cleared labeling specifically permits otherwise.
- MRI safety is not clinically relevant for routine use because the interface is used during eye surgery and is not intended to remain implanted.
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.