📋 FDA Reference
Soflex Soft K Xylofilcon a Soft Hydrophilic Keratoconus Contact Lens for Daily Wear
Soflex Contact Lens Industries
Summary: The Soflex Soft K Xylofilcon A is a soft hydrophilic contact lens designed for daily wear by patients with keratoconus. It is used by optometrists and ophthalmologists to improve visual acuity in affected individuals.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K033655 ↗
Decision Date ?
July 30, 2004
Product Code ?
LPL
Device Class ?
Class 2
Evidence ?
419 studies
The Soflex Soft K Xylofilcon A was cleared through the FDA 510(k) pathway on July 30, 2004. Manufactured by Soflex Contact Lens Industries, it is classified as a Class 2 medical device.
What It Is
The Soflex Soft K Xylofilcon A is a specialized contact lens made from a soft hydrophilic material, designed specifically for patients with keratoconus. This condition causes a conical deformation of the cornea, leading to distorted vision. The lens works by providing a smooth refractive surface, thereby improving visual acuity. Its daily wear design ensures comfort and ease of use for patients.
FDA-Cleared Indications
- Correction of refractive errors in patients with keratoconus.
- Daily wear use.
Clinical Applications
- Daily-wear vision correction for patients with keratoconus.
- Correction of blurred or distorted vision caused by keratoconus-related corneal irregularity.
- Fitting by an eye-care professional when glasses do not provide satisfactory visual correction.
Practical Considerations
- The lens should be fitted by an optometrist or ophthalmologist using the patient's corneal shape, prescription and comfort as guides.
- Patients should follow prescribed cleaning, disinfection, insertion and removal instructions; the lens should not be worn overnight unless specifically directed by the prescriber.
- Contact lenses can cause corneal infection, inflammation, abrasion or reduced oxygen delivery if poorly fitted, over-worn or inadequately cleaned. Eye pain, redness, discharge or sudden vision changes require prompt eye-care evaluation.
- This is a soft hydrophilic lens, not an implanted device, and it is removed from the eye for cleaning or replacement according to the prescribing clinician's schedule.
- MRI compatibility is generally not a device concern because the lens is nonmetallic and worn on the eye, but patients should follow the imaging center's instructions and disclose that they wear contact lenses.
Linked Studies (20)
PubMed • 2025
Onyx Liquid Embolic Agent: Basic Knowledge for Its Use in Interventional Neuroradiology.
Journal of neuroendovascular therapy
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Performance evaluation of quantitative hemoglobin A2 and fetal hemoglobin testing using commercially lyophilized vs. in-house whole blood controls in Chinese clinical laboratories: a 12-year analysis of National External Quality Assessment Data.
Clinical chemistry and laboratory medicine
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Clinical progress note: Haemophilus influenzae type b.
Journal of hospital medicine
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Pilot study of social media promotion of home-based self-testing for syphilis.
Sexually transmitted diseases
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Clinical development and performance of the First to Know Syphilis Self-Test for over-the-counter usage: a de novo rapid test for treponemal antibody.
Journal of clinical microbiology
View Source →PubMed • 2025
Implementation of an Opt-Out and Rapid Point-of-Care Syphilis Testing Program for Pregnant Patients Presenting to the Emergency Department.
Sexually transmitted diseases
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Evaluation of Rapid Syphilis Testing Using the Syphilis Health Check in Florida, 2015-2016.
Florida public health review
View Source →PubMed • 2025
Multiplex droplet digital PCR for the detection and quantitation of Streptococcus pneumoniae, Mycoplasma pneumoniae, and Haemophilus influenzae.
Frontiers in cellular and infection microbiology
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Palm Multidiagnostic of Mycoplasma pneumoniae, Chlamydia pneumoniae, Haemophilus influenzae, and Streptococcus pneumoniae Using One-Tube CRISPR/Cas12a.
Transboundary and emerging diseases
View Source →PubMed • 2025
Tp40: a new potential prognostic and diagnostic marker for syphilis.
Microbiology spectrum
View Source →PubMed • 2025
Serotonin sets up neutrophil extracellular traps to promote neuroendocrine prostate cancer metastasis in the liver.
The Journal of clinical investigation
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Application value of Philips Ingenuity TF PET/CT scanner imaging agent FAP in evaluating renal fibrosis.
Hellenic journal of nuclear medicine
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Message from Dr. Philippe T. Georgel, Guest Editor for the Marshall University Collection, Brad D. Smith, President of Marshall University, and Dr. Anivandan Mukherjee, Provost of Marshall University.
Biochemistry and cell biology = Biochimie et biologie cellulaire
View Source →PubMed • 2025
Improved patient comfort and procedural efficiency using chlorhexidine-coated hydrophilic urethral catheters: a randomized controlled trial.
Journal of Yeungnam medical science
RCT View Source →PubMed • 2025
pTx-Pulseq in hybrid sequences: Accessible and advanced hybrid open-source MRI sequences on Philips scanners.
Magnetic resonance in medicine
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Comparative connectomics of Drosophila descending and ascending neurons.
Nature
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Hydrophilic-coated sheaths for reducing radial artery spasm during transradial procedures: A systematic review and meta-analysis.
Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences
View Source →PubMed • 2025
History of antineutrophil cytoplasmic autoantibodies : Milestones in rheumatology.
Zeitschrift fur Rheumatologie
View Source →PubMed • 2025
A Hydrophilic Polyurethane Foam Containing Nigella sativa Oil as a Wound Dressing.
BioMed research international
RCT|prospective|retrospective|case Series|other View Source →Frequently Asked Questions
What is the Soflex Soft K Xylofilcon A Contact Lens used for?
It is used to correct refractive errors in patients with keratoconus, improving their visual acuity.
What specialties typically use this device?
Optometrists and ophthalmologists typically use this device in clinical settings.
What are the FDA-cleared indications?
The lens is indicated for daily wear to correct vision in patients with keratoconus.
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.