📋 FDA Reference
Pegavision Hioxifilcon a One-Day Soft Hydrophilic Contact Lenses 59 Water
Pegavision
Summary: Pegavision Hioxifilcon A One-Day Soft Hydrophilic Contact Lenses are daily disposable lenses used for vision correction. They are primarily used by optometrists and ophthalmologists for patients needing vision correction.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K222885 ↗
Decision Date ?
May 31, 2023
Product Code ?
LPL
Device Class ?
Class 2
Evidence ?
419 studies
The Pegavision Hioxifilcon A contact lenses were cleared through the FDA 510k pathway on May 31, 2023. Manufactured by Pegavision, these lenses are classified as Class 2 medical devices.
What It Is
These are daily disposable soft contact lenses made from Hioxifilcon A, a hydrophilic material containing 59% water. The lenses are designed to provide comfort and clear vision by maintaining moisture throughout the day. They are intended for single-use, reducing the risk of eye infections associated with extended wear.
FDA-Cleared Indications
- Daily disposable soft contact lenses for correcting refractive errors.
- Intended for single-day wear and disposal after removal.
- Made from hioxifilcon A hydrophilic lens material with 59% water content.
Clinical Applications
- Daily vision correction for myopia, or nearsightedness.
- Daily vision correction for hyperopia, or farsightedness.
- Use in patients who require soft contact lenses fitted by an optometrist or ophthalmologist.
- Single-use daily wear when a disposable contact-lens option is selected by an eye-care professional.
Practical Considerations
- The lenses are available in prescription powers selected to match the patient's refractive error and require professional fitting.
- Each lens is intended for one day of wear and should be discarded after removal; it should not be cleaned, stored, or reused.
- Patients should follow the prescribed wearing schedule and contact an eye-care professional for pain, redness, discharge, blurred vision, or persistent discomfort.
- The lenses are not intended for overnight or extended wear unless the product labeling specifically permits it.
- Contact lenses are not relevant to MRI compatibility because they are worn on the eye and contain no implanted electronic component; patients should still follow the imaging facility's instructions.
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 Pegavision Hioxifilcon A Contact Lenses used for?
They are used for correcting refractive vision errors such as myopia and hyperopia.
What specialties typically use this device?
Optometrists and ophthalmologists typically use these lenses in their practice.
What are the FDA-cleared indications?
These lenses are indicated for daily wear to correct refractive vision errors in patients.
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.