đź“‹ FDA Reference

aquamax etafilcon a daily disposable soft hydrophilic contact lenses aquamax etafilcon a soft hydrophilic contact lenses

Pegavision

Summary: Aquamax Etafilcon A are daily disposable soft hydrophilic contact lenses used for vision correction. Designed for ease of use, they are typically used by optometrists and ophthalmologists for patients needing corrective lenses.

FDA Clearance Information

Pathway 510K
Decision Date December 6, 2021
Product Code LPL
Device Class Class 2
Evidence 419 studies

The Aquamax Etafilcon A contact lenses by Pegavision were cleared via the FDA 510(k) pathway on December 6, 2021. They are classified as Class 2 medical devices.

What It Is

These are daily disposable soft contact lenses made from Etafilcon A, a hydrophilic material that allows for high oxygen permeability. They are designed to provide comfort and clear vision for individuals with refractive errors such as myopia or hyperopia. The lenses are intended for single-day use, reducing the risk of infection and eliminating the need for cleaning solutions.

Clinical Applications

Aquamax Etafilcon A lenses are commonly used in optometry and ophthalmology clinics for patients needing vision correction. They are suitable for a wide range of refractive errors and are particularly beneficial for patients who prefer the convenience of daily disposables. These lenses are ideal for active individuals or those with busy lifestyles who prioritize ease of use and hygiene.

Indications for Use

These contact lenses are indicated for daily wear to correct refractive errors like nearsightedness and farsightedness. They are suitable for patients who prefer not to wear glasses or who need an alternative for specific activities.

Practical Considerations

Aquamax lenses come in various powers to accommodate different levels of vision correction. They are designed for single-day use, which means they should be discarded after each wear. This reduces the need for lens care products and minimizes the risk of lens-related complications.

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 Aquamax Etafilcon A used for?

Aquamax Etafilcon A contact lenses are used for correcting refractive errors such as myopia and hyperopia.

What specialties typically use this device?

Optometrists and ophthalmologists typically use these lenses in clinical practice for vision correction.

What are the FDA-cleared indications?

These lenses are indicated for daily wear to correct refractive errors like nearsightedness and 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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