đź“‹ FDA Reference
desio polymacon daily wear soft hydrophilic contact lenses clear and tinted
Qualimed Srl
Summary: Desio Polymacon Daily Wear Soft Hydrophilic Contact Lenses are used for vision correction. They are suitable for patients needing daily wear lenses, available in clear and tinted options.
FDA Clearance Information
Pathway
510K
Number
K142384 ↗
Decision Date
December 12, 2014
Product Code
LPL
Device Class
Class 2
Evidence
419 studies
The Desio Polymacon Contact Lenses were cleared through the FDA 510(k) pathway on December 12, 2014. Manufactured by Qualimed Srl, they are classified as Class 2 medical devices.
What It Is
Desio Polymacon Contact Lenses are soft hydrophilic lenses designed for daily wear. They are made from a material called polymacon, which is known for its water-absorbing properties, providing comfort and moisture retention. These lenses are available in both clear and tinted versions, offering options for aesthetic preferences or specific visual needs.
Clinical Applications
These contact lenses are primarily used in optometry and ophthalmology for patients requiring vision correction. They are suitable for individuals with myopia or hyperopia, providing an alternative to glasses. The tinted versions can also be used for cosmetic purposes, enhancing or changing eye color, which may appeal to a younger demographic or those interested in aesthetic changes.
Indications for Use
The FDA-cleared indications for these lenses include daily wear for vision correction in patients with refractive errors. They are suitable for individuals needing corrective lenses for nearsightedness or farsightedness.
Practical Considerations
These lenses are typically available in a range of diopters to accommodate various levels of vision correction. They should be fitted by an eye care professional to ensure proper fit and comfort. The lenses are designed for daily wear, meaning they should be removed and cleaned each night.
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 Desio Polymacon Contact Lenses used for?
They are used for correcting refractive errors such as myopia and hyperopia, and are available in both clear and tinted options for daily wear.
What specialties typically use this device?
Optometrists and ophthalmologists typically prescribe and fit these contact lenses for patients requiring vision correction.
What are the FDA-cleared indications?
The 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.