📋 FDA Reference
Aquamax Polymacon Disposable Soft Hydrophilic Contact Lenses
Pegavision
Summary: Aquamax Polymacon disposable soft hydrophilic contact lenses are used for vision correction in patients with refractive errors. They are primarily used by optometrists and ophthalmologists.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K123973 ↗
Decision Date ?
April 23, 2013
Product Code ?
LPL
Device Class ?
Class 2
Evidence ?
419 studies
The Aquamax Polymacon contact lenses were cleared through the FDA 510(k) pathway on April 23, 2013. Manufactured by Pegavision, this Class 2 device is intended for vision correction.
What It Is
The Aquamax Polymacon disposable soft hydrophilic contact lenses are designed to correct refractive errors such as myopia and hyperopia. Made from polymacon, a hydrogel material, these lenses allow oxygen permeability to maintain corneal health. They are intended for daily wear and are disposable, promoting convenience and hygiene.
FDA-Cleared Indications
- Correction of refractive errors, including myopia and hyperopia.
- Daily-wear vision correction with disposable soft hydrophilic contact lenses.
Clinical Applications
- Correction of nearsightedness in patients prescribed an appropriate lens power.
- Correction of farsightedness in patients prescribed an appropriate lens power.
- Daily contact-lens wear as an alternative to eyeglasses for prescribed refractive correction.
- Outpatient fitting and use under the direction of an eye-care professional.
Practical Considerations
- The lenses require professional fitting and a prescription matched to the patient's refractive error and ocular measurements.
- Patients should receive instruction on hand hygiene, insertion, removal, cleaning if applicable, and disposal according to the product labeling.
- Daily-wear lenses should not be worn overnight unless the specific product labeling expressly permits it.
- Patients with active eye infection, significant ocular surface disease, or an inability to follow lens-care instructions may not be appropriate candidates.
- These lenses are worn on the cornea and do not require MRI precautions; they should be removed if requested by the imaging facility.
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 Polymacon Contact Lenses used for?
They are used for correcting refractive errors like 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?
The lenses are indicated for the correction of refractive errors such as 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.