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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
510K
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.
Clinical Applications
This device is commonly used in refractive surgery settings, particularly in LASIK procedures to correct vision issues such as myopia, hyperopia, and astigmatism. Ophthalmologists in specialized eye clinics and surgical centers utilize this technology to enhance surgical precision and patient outcomes. The patient interface is designed to work seamlessly with the FS200 laser, providing a stable and reliable platform for flap creation.
Indications for Use
The Wavelight FS200 Patient Interface 1505 is indicated for use in patients undergoing LASIK surgery to correct refractive errors. It is suitable for individuals seeking to reduce their dependence on glasses or contact lenses by reshaping the cornea to improve vision.
Practical Considerations
The device is compatible with the FS200 femtosecond laser system and requires proper alignment and calibration for optimal performance. Clinicians should be trained in its use to ensure precise flap creation and avoid potential complications. The interface is designed for single-use to maintain sterility and prevent cross-contamination.
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.