📋 FDA Reference
Innova Vision Hydrogel Hioxifilcon a Soft Hydrophilic Contact Lens
Innova Vision
Summary: The Innova Vision Hydrogel Hioxifilcon A is a soft hydrophilic contact lens used for vision correction. It is primarily used by optometrists and ophthalmologists for patients requiring corrective lenses.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K213119 ↗
Decision Date ?
May 13, 2022
Product Code ?
LPL
Device Class ?
Class 2
Evidence ?
419 studies
The Innova Vision Hydrogel Hioxifilcon A lens was cleared via the FDA 510k pathway on May 13, 2022. Manufactured by Innova Vision, it is a Class 2 medical device.
What It Is
The Innova Vision Hydrogel Hioxifilcon A is a soft contact lens designed to correct refractive errors such as myopia or hyperopia. Made from a hydrophilic material, it allows oxygen to pass through to the cornea, enhancing comfort and wearability. This lens is designed for daily wear and provides a convenient alternative to glasses.
FDA-Cleared Indications
- Correction of refractive errors, including myopia and hyperopia, with a soft hydrophilic contact lens.
- Daily-wear vision correction when prescribed and fitted by an eye-care professional.
Clinical Applications
- Correction of nearsightedness with a prescribed contact-lens power.
- Correction of farsightedness with a prescribed contact-lens power.
- Daily-wear contact-lens vision correction in patients appropriately evaluated and fitted by an optometrist or ophthalmologist.
- Outpatient contact-lens fitting and follow-up for refractive-error correction.
Practical Considerations
- The lens must be fitted and prescribed by an eye-care professional; available powers, curves and diameters should be selected for the individual eye.
- Follow the labeled wear schedule, replacement schedule and cleaning instructions. Do not use tap water or share lenses.
- Proper hand hygiene, lens disinfection and storage are important to reduce the risk of eye infection and corneal injury.
- Patients with active eye infection, significant ocular inflammation or an eye-care professional's contraindication should not wear the lens until medically cleared.
- A contact lens is not an implanted device and does not require MRI-specific precautions; remove it if directed before an eye or imaging examination.
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 Innova Vision Hydrogel Hioxifilcon A lens used for?
It is used for correcting refractive errors like myopia and hyperopia.
What specialties typically use this device?
Optometrists and ophthalmologists typically use this device.
What are the FDA-cleared indications?
It is indicated for vision correction in patients with refractive errors such as nearsightedness or farsightedness.
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.