đź“‹ FDA Reference
Wavelight FS200 Patient Interface 1505
Alcon Research
Summary: The Wavelight FS200 Patient Interface 1505 is a device used in LASIK eye surgery to create corneal flaps with precision. It is primarily used by ophthalmologists specializing in refractive surgery.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K121031 ↗
Decision Date ?
June 21, 2012
Product Code ?
GEX
Device Class ?
Class 2
Evidence ?
0 studies
The Wavelight FS200 Patient Interface 1505, manufactured by Alcon Research, was cleared via the FDA 510(k) pathway on June 21, 2012. It is a Class 2 medical device under product code GEX.
What It Is
The Wavelight FS200 Patient Interface 1505 is a component of the FS200 femtosecond laser system, designed to assist in creating corneal flaps during LASIK surgery. It uses a femtosecond laser to deliver precise and controlled energy bursts, allowing for accurate flap creation. This device is crucial for ensuring the safety and effectiveness of the LASIK procedure, minimizing complications and improving visual outcomes.
FDA-Cleared Indications
- Use with the Wavelight FS200 femtosecond laser system during LASIK procedures.
- Creation of a corneal flap before excimer-laser treatment of refractive errors, including myopia, hyperopia, and astigmatism, when performed according to the system's FDA-cleared labeling.
Clinical Applications
- Patient-interface support and eye stabilization during LASIK flap creation.
- Femtosecond-laser creation of a corneal flap before corneal reshaping with an excimer laser.
- Use in refractive surgery for appropriately selected patients with myopia, hyperopia, or astigmatism.
Practical Considerations
- The interface is designed for compatibility with the Wavelight FS200 femtosecond laser and should not be substituted across systems unless specifically authorized by the manufacturer.
- Correct patient positioning, docking, alignment, and suction are required for stable laser delivery and safe flap creation.
- It is a patient-contact component intended for single use according to the supplied device information; follow institutional sterilization and disposal policies.
- The device is used on the eye and is not an implant or an intravascular device. MRI safety labeling is generally not relevant, but the complete system labeling should be checked if a patient has an implanted or retained ophthalmic component.
- Potential problems relate primarily to docking or flap creation, including suction loss, incomplete or irregular flaps, epithelial injury, or other LASIK-related complications.
Related Literature
The linked study evaluated the safety and efficacy of a novel LASIK flap patient interface cone compared to the standard metal and glass interface when used with the FS200 laser. The study found that the novel interface provided comparable flap parameters, suggesting it is a viable alternative. However, the study's limitations include its focus on specific flap parameters and the need for further research to confirm long-term outcomes.
Frequently Asked Questions
What is the Wavelight FS200 Patient Interface 1505 used for?
It is used in LASIK surgery to create precise corneal flaps, a critical step in the procedure.
What specialties typically use this device?
Ophthalmologists specializing in refractive surgery commonly use this device.
What are the FDA-cleared indications?
The device is indicated for use in LASIK procedures to correct refractive errors such as myopia, hyperopia, and astigmatism.
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.