đź“‹ FDA Reference
eni-eye sh soft k semi scleral efrofilcon a soft hydrophilic keratoconus and irregular cor eni-eye sh soft k toric s
Soflex
Summary: The eni-eye sh soft k is a semi-scleral soft contact lens designed for patients with keratoconus and irregular corneas. It is primarily used by optometrists and ophthalmologists to improve vision in these patients.
FDA Clearance Information
Pathway
510K
Number
K122220 ↗
Decision Date
March 19, 2013
Product Code
LPL
Device Class
Class 2
Evidence
419 studies
The eni-eye sh soft k, manufactured by Soflex, received FDA clearance through the 510(k) pathway on March 19, 2013. It is classified as a Class 2 medical device under product code LPL.
What It Is
The eni-eye sh soft k is a semi-scleral, hydrophilic contact lens made from efrofilcon A. It is specifically designed to fit irregular corneal surfaces, such as those found in keratoconus patients. The lens provides a larger diameter than standard soft lenses, offering improved stability and comfort by vaulting over the cornea and resting on the sclera.
Clinical Applications
This device is commonly used in optometry and ophthalmology practices for patients with keratoconus or other corneal irregularities. It is particularly beneficial in cases where traditional contact lenses are ineffective or uncomfortable. The lens is fitted in a clinical setting, often requiring specialized training to ensure proper fit and patient comfort.
Indications for Use
The FDA indications for the eni-eye sh soft k include its use in patients with keratoconus and irregular corneas. This means it is intended for individuals whose corneal shape prevents them from achieving clear vision with standard contact lenses.
Practical Considerations
When fitting the eni-eye sh soft k, clinicians should consider the lens's larger diameter and its semi-scleral design, which requires careful assessment of the corneal and scleral topography. Compatibility with the patient's ocular surface and tear film stability is crucial for optimal performance.
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
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PubMed • 2025
Evaluation of Rapid Syphilis Testing Using the Syphilis Health Check in Florida, 2015-2016.
Florida public health review
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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
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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 the eni-eye sh soft k used for?
It is used to improve vision in patients with keratoconus and irregular corneas.
What specialties typically use this device?
Optometrists and ophthalmologists typically use this device.
What are the FDA-cleared indications?
The device is indicated for use in patients with keratoconus and irregular corneas.
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.