đź“‹ FDA Reference
giselle polymacon daily wear soft hydrophilic contact lenses clear and tinted
I-Codi
Summary: Giselle Polymacon daily wear soft hydrophilic contact lenses, available in clear and tinted options, are used for vision correction. They are typically prescribed by optometrists and ophthalmologists for patients needing refractive correction.
FDA Clearance Information
Pathway
510K
Number
K143431 ↗
Decision Date
February 20, 2015
Product Code
LPL
Device Class
Class 2
Evidence
419 studies
The Giselle Polymacon contact lenses were cleared through the FDA 510k pathway on February 20, 2015. Manufactured by I-Codi, these lenses are classified as Class 2 medical devices.
What It Is
The Giselle Polymacon contact lenses are soft, hydrophilic lenses designed for daily wear. Made from polymacon, a hydrogel material, these lenses allow oxygen to pass through to the cornea, promoting comfort and eye health. They are available in both clear and tinted varieties, catering to different patient preferences.
Clinical Applications
These contact lenses are primarily used in the field of optometry and ophthalmology for correcting refractive errors such as myopia, hyperopia, and astigmatism. They are suitable for patients seeking an alternative to eyeglasses for vision correction. The lenses can be used in various settings, including private practices, clinics, and hospitals, and are appropriate for a wide range of patient demographics.
Indications for Use
The FDA indications suggest these lenses are for patients needing vision correction due to refractive errors. They are suitable for daily wear and can be used by individuals who prefer contact lenses over traditional eyeglasses.
Practical Considerations
These lenses are typically available in various sizes to fit different corneal shapes and sizes. Clinicians should ensure proper fitting and educate patients on lens care and hygiene to prevent complications. Compatibility with other ophthalmic products should be verified before use.
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 Giselle Polymacon Contact Lenses used for?
These lenses are used for correcting refractive errors such as myopia, hyperopia, and astigmatism.
What specialties typically use this device?
Optometrists and ophthalmologists typically prescribe these contact lenses.
What are the FDA-cleared indications?
These lenses are indicated for daily wear to correct refractive errors in patients seeking an alternative to eyeglasses.
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.