đź“‹ FDA Reference
aveo omafilcon a soft hydrophilic contact lenses
Supervision Optimax Sdn Bhd
Summary: The aveo omafilcon a soft hydrophilic contact lenses are designed for vision correction and are used by optometrists and ophthalmologists. They are suitable for patients requiring daily wear contact lenses.
FDA Clearance Information
Pathway
510K
Number
K180985 ↗
Decision Date
June 8, 2018
Product Code
LPL
Device Class
Class 2
Evidence
419 studies
The aveo omafilcon a soft hydrophilic contact lenses were cleared via the FDA 510k pathway on June 8, 2018. Manufactured by Supervision Optimax Sdn Bhd, this Class 2 device is categorized under product code LPL.
What It Is
The aveo omafilcon a soft hydrophilic contact lenses are daily wear lenses made from omafilcon A, a material known for its high water content and oxygen permeability. These lenses are designed to provide comfort and clear vision for individuals with refractive errors such as myopia or hyperopia. The hydrophilic nature of the lenses helps maintain moisture, reducing dryness and discomfort for the wearer.
Clinical Applications
These contact lenses are commonly used in optometry and ophthalmology clinics for patients seeking an alternative to glasses for vision correction. They are suitable for a wide range of patients, including those with active lifestyles or those who prefer the aesthetic and functional benefits of contact lenses over spectacles. The lenses are typically prescribed for daily wear and are replaced on a regular schedule as advised by the eye care professional.
Indications for Use
The FDA-cleared indications for these lenses are for the correction of refractive errors such as nearsightedness or farsightedness. They are intended for patients who require vision correction and prefer contact lenses as their method of correction.
Practical Considerations
These lenses are available in various diopter strengths to accommodate different levels of vision correction. They are designed for daily wear and should be removed before sleeping. Proper hygiene and lens care are essential to prevent infections and ensure optimal lens performance.
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 aveo omafilcon a soft hydrophilic contact lenses used for?
These lenses are used for correcting refractive errors like myopia and hyperopia, providing clear vision for daily activities.
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 such as nearsightedness or farsightedness 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.