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aquamax etafilcon a bi-weekly disposable soft hydrophilic contact lenses
Pegavision
Summary: The Aquamax Etafilcon A are bi-weekly disposable soft contact lenses used to correct refractive errors such as myopia and hyperopia. They are typically used by optometrists and ophthalmologists for patients requiring vision correction.
FDA Clearance Information
Pathway
510K
Number
K140025 ↗
Decision Date
October 15, 2014
Product Code
LPL
Device Class
Class 2
Evidence
419 studies
The Aquamax Etafilcon A lenses were cleared through the FDA 510(k) pathway on October 15, 2014, by Pegavision. They are classified as Class 2 medical devices under product code LPL.
What It Is
The Aquamax Etafilcon A lenses are soft, hydrophilic contact lenses designed for bi-weekly disposal. Made from etafilcon A, a hydrogel material, these lenses offer comfort and moisture retention, making them suitable for daily wear. They correct common refractive errors, providing clear vision for patients with myopia (nearsightedness) or hyperopia (farsightedness).
Clinical Applications
These contact lenses are primarily used in optometry and ophthalmology settings for patients requiring vision correction. They are suitable for individuals seeking a convenient and comfortable alternative to glasses. The lenses are commonly prescribed for patients who prefer the flexibility of contact lenses and are compliant with regular lens replacement schedules.
Indications for Use
The FDA-cleared indications for these lenses include correction of refractive errors such as myopia and hyperopia. They are intended for patients who need vision correction and prefer contact lenses over eyeglasses.
Practical Considerations
The lenses are available in various powers to accommodate different levels of refractive error. They are designed for bi-weekly replacement, requiring patients to adhere to a regular replacement schedule to maintain eye health and lens performance. Proper lens hygiene and handling are essential to prevent infections and ensure comfort.
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 Aquamax Etafilcon A used for?
Aquamax Etafilcon A lenses are used to correct refractive errors such as myopia and hyperopia, providing clear vision for patients.
What specialties typically use this device?
Optometrists and ophthalmologists typically prescribe these lenses for patients needing vision correction.
What are the FDA-cleared indications?
The lenses are indicated for the correction of refractive errors like myopia and hyperopia in patients who prefer contact lenses.
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.