đź“‹ FDA Reference
qualis linofilcon a soft hydrophilic daily wear contact lens
Unicon Optical
Summary: The Qualis Linofilcon A is a daily wear, soft hydrophilic contact lens designed for vision correction. It is typically used by optometrists and ophthalmologists for patients needing corrective lenses.
FDA Clearance Information
Pathway
510K
Number
K213216 ↗
Decision Date
January 18, 2022
Product Code
LPL
Device Class
Class 2
Evidence
419 studies
The Qualis Linofilcon A contact lens was cleared through the FDA 510(k) pathway on January 18, 2022. Manufactured by Unicon Optical, it is classified as a Class 2 medical device.
What It Is
The Qualis Linofilcon A is a silicone hydrogel contact lens intended for daily wear. It is designed to be soft and hydrophilic, enhancing comfort and oxygen permeability. These lenses are used to correct refractive errors such as myopia and hyperopia, providing a convenient alternative to glasses.
Clinical Applications
These contact lenses are commonly used in optometry and ophthalmology practices for patients requiring vision correction. They are suitable for a wide range of patients, including those with active lifestyles who prefer the convenience of disposable lenses. The lenses are typically prescribed in outpatient settings and can be used by adults and teenagers.
Indications for Use
The FDA indications suggest that these lenses are for daily wear to correct refractive errors like nearsightedness or farsightedness. They are suitable for patients who prefer contact lenses over glasses for vision correction.
Practical Considerations
The lenses are available in various powers to match the patient's prescription. They should be fitted by a qualified eye care professional to ensure proper fit and comfort. Users should follow proper hygiene and handling instructions to avoid infections.
Related Literature
The linked study evaluated the clinical performance and safety of Unicon's silicone hydrogel daily disposable lenses. While specific results are not available, such studies typically assess comfort, visual acuity, and safety over a period of wear. Limitations may include a small sample size or short duration, which could affect the generalizability of the findings.
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 Qualis Linofilcon A used for?
It is used for correcting refractive errors such as myopia and hyperopia in patients who prefer contact lenses over glasses.
What specialties typically use this device?
Optometrists and ophthalmologists commonly prescribe these lenses for vision correction.
What are the FDA-cleared indications?
The lenses are indicated for daily wear to correct refractive errors like nearsightedness or 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.