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calaview color etafilcon a soft hydrophilic contact lens for daily wear modification
Innova Vision
Summary: The Calaview Color Etafilcon A is a soft hydrophilic contact lens designed for daily wear, providing vision correction with added cosmetic enhancement. It is used by optometrists and ophthalmologists for patients seeking both vision correction and cosmetic eye color change.
FDA Clearance Information
Pathway
510K
Number
K112373 ↗
Decision Date
August 17, 2012
Product Code
LPL
Device Class
Class 2
Evidence
419 studies
The Calaview Color Etafilcon A contact lens was cleared through the FDA 510(k) pathway on August 17, 2012, by Innova Vision. It is classified as a Class 2 medical device under product code LPL.
What It Is
The Calaview Color Etafilcon A is a soft, hydrophilic contact lens intended for daily wear. Made from etafilcon A, it is designed to correct refractive errors such as myopia or hyperopia while also providing a cosmetic change to the eye's appearance with its color options. The lens allows for oxygen permeability, ensuring comfort and eye health during wear.
Clinical Applications
These contact lenses are commonly used in optometry and ophthalmology settings for patients who require vision correction and desire a cosmetic change in eye color. They are suitable for individuals with refractive errors who prefer the convenience and aesthetic appeal of contact lenses over glasses. The lenses are typically prescribed in outpatient settings and are popular among young adults and fashion-conscious individuals.
Indications for Use
The FDA indications for these lenses include correction of refractive errors such as nearsightedness or farsightedness, along with cosmetic enhancement of eye color. They are suitable for patients who want both vision correction and a change in the appearance of their eyes.
Practical Considerations
These lenses are available in various colors and powers to suit different refractive needs and aesthetic preferences. They are designed for daily wear, meaning they should be removed and cleaned each night. Compatibility with standard contact lens solutions is generally expected, but specific recommendations may vary.
Related Literature
The linked study investigated the use of Nile Red and Oil Red O stains to detect tear film lipids deposited on silicone hydrogel contact lenses. The study found that these stains were effective in identifying lipid deposits, which can affect lens comfort and performance. However, the study was limited to silicone hydrogel lenses and did not directly address etafilcon A lenses, which may have different lipid deposition characteristics.
Linked Studies (20)
PubMed • 2025
Onyx Liquid Embolic Agent: Basic Knowledge for Its Use in Interventional Neuroradiology.
Journal of neuroendovascular therapy
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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
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PubMed • 2025
Clinical progress note: Haemophilus influenzae type b.
Journal of hospital medicine
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PubMed • 2025
Pilot study of social media promotion of home-based self-testing for syphilis.
Sexually transmitted diseases
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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
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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
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PubMed • 2025
Palm Multidiagnostic of Mycoplasma pneumoniae, Chlamydia pneumoniae, Haemophilus influenzae, and Streptococcus pneumoniae Using One-Tube CRISPR/Cas12a.
Transboundary and emerging diseases
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PubMed • 2025
Tp40: a new potential prognostic and diagnostic marker for syphilis.
Microbiology spectrum
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PubMed • 2025
Serotonin sets up neutrophil extracellular traps to promote neuroendocrine prostate cancer metastasis in the liver.
The Journal of clinical investigation
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PubMed • 2025
Application value of Philips Ingenuity TF PET/CT scanner imaging agent FAP in evaluating renal fibrosis.
Hellenic journal of nuclear medicine
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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
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PubMed • 2025
pTx-Pulseq in hybrid sequences: Accessible and advanced hybrid open-source MRI sequences on Philips scanners.
Magnetic resonance in medicine
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PubMed • 2025
Comparative connectomics of Drosophila descending and ascending neurons.
Nature
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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 Calaview Color Etafilcon A used for?
It is used for correcting refractive errors like myopia or hyperopia and for cosmetic eye color enhancement.
What specialties typically use this device?
Optometrists and ophthalmologists typically prescribe these lenses.
What are the FDA-cleared indications?
The lenses are indicated for vision correction and cosmetic eye color change for individuals with refractive errors.
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.