đź“‹ FDA Reference
largan u38 polymacon daily wear soft hydrophilic contact lens largan u38 polymacon daily wear soft hydrophilic contact lens for astigmatism largan u38 polymacon daily wear soft hydrophilic contact lens for presbyopia
Largan Medical
Summary: The Largan U38 Polymacon is a daily wear soft hydrophilic contact lens designed for regular vision correction, astigmatism, and presbyopia. It is used by optometrists and ophthalmologists for patients requiring vision correction.
FDA Clearance Information
Pathway
510K
Number
K182674 ↗
Decision Date
November 13, 2018
Product Code
LPL
Device Class
Class 2
Evidence
419 studies
The Largan U38 Polymacon contact lens was cleared through the FDA 510(k) pathway on November 13, 2018, by Largan Medical. It is a Class 2 medical device.
What It Is
The Largan U38 Polymacon is a soft hydrophilic contact lens intended for daily wear. It is made from polymacon, a hydrogel material that retains moisture, providing comfort for the wearer. The lens is available in configurations for standard vision correction, astigmatism, and presbyopia, offering a versatile solution for various refractive errors.
Clinical Applications
These lenses are commonly used in optometry and ophthalmology settings for patients who require correction for myopia, hyperopia, astigmatism, or presbyopia. They are suitable for patients seeking a comfortable, daily wear contact lens option. The lenses are typically prescribed for adults and adolescents who prefer contact lenses over glasses for vision correction.
Indications for Use
The lenses are indicated for daily wear to correct refractive errors such as nearsightedness, farsightedness, astigmatism, and presbyopia. They are suitable for individuals who need vision correction and prefer the convenience of contact lenses.
Practical Considerations
The lenses are available in various sizes and prescriptions to accommodate different patient needs. They are designed for daily wear and should be removed before sleeping. Proper lens care and hygiene 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 Largan U38 Polymacon Contact Lens used for?
It is used for correcting vision in individuals with myopia, hyperopia, astigmatism, and presbyopia.
What specialties typically use this device?
Optometrists and ophthalmologists typically prescribe these lenses for vision correction.
What are the FDA-cleared indications?
The lenses are cleared for daily wear to correct refractive errors such as nearsightedness, farsightedness, astigmatism, and presbyopia.
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.