đź“‹ 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 510K
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.

Clinical Applications

These lenses are commonly used in optometry and ophthalmology clinics for patients who need vision correction. They are suitable for a wide range of patients, including those with mild to moderate refractive errors. The lenses are typically fitted by eye care professionals in outpatient settings and are popular among patients who prefer contact lenses over glasses for aesthetic or lifestyle reasons.

Indications for Use

The FDA indications suggest that this lens is intended for vision correction in patients with refractive errors such as nearsightedness or farsightedness. It is suitable for individuals who prefer contact lenses as their primary method of vision correction.

Practical Considerations

These lenses are available in various sizes and prescriptions to fit different patient needs. They are compatible with standard contact lens solutions and require proper hygiene and handling to ensure safety and effectiveness. Clinicians should ensure proper fitting to maximize comfort and visual acuity.

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

Editorial - Philippe Ascher (1936-2022).

Neuroscience

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.

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