đź“‹ FDA Reference

sauflon clariti 1 day somofilcon a soft hydrophilic daily disposable contact lens with uv blocker

Sauflon Pharmaceuticals

Summary: The sauflon clariti 1 day is a daily disposable contact lens designed for vision correction and UV protection. It is used by optometrists and ophthalmologists for patients requiring convenient, single-use lenses.

FDA Clearance Information

Pathway 510K
Decision Date July 26, 2013
Product Code MVN
Device Class Class 2
Evidence 419 studies

The sauflon clariti 1 day contact lens was cleared through the FDA 510(k) pathway on July 26, 2013. Manufactured by Sauflon Pharmaceuticals, it is classified as a Class 2 medical device under product code MVN.

What It Is

The sauflon clariti 1 day is a soft hydrophilic contact lens made from somofilcon A, designed for daily wear and disposal. It incorporates a UV blocker to protect the eyes from harmful ultraviolet rays. The lens offers convenience and hygiene benefits by eliminating the need for cleaning and storage, making it ideal for patients with active lifestyles.

Clinical Applications

This contact lens is commonly used in optometry and ophthalmology settings for patients requiring vision correction for conditions such as myopia or hyperopia. It is particularly beneficial for individuals who prefer the convenience of daily disposables and for those who are prone to allergies or infections from extended lens wear. The lenses are suitable for a wide range of patients, including those with sensitive eyes.

Indications for Use

The FDA indications for this contact lens include vision correction for refractive errors like nearsightedness and farsightedness. It is intended for daily wear and provides added protection against UV radiation, making it suitable for patients who spend significant time outdoors.

Practical Considerations

These lenses are available in a variety of powers to accommodate different levels of refractive error. They are designed for single-day use, meaning they should be discarded after one day of wear. Clinicians should ensure proper fit and comfort for each patient, and educate them on the importance of daily replacement to maintain eye health.

Linked Studies (20)

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Onyx Liquid Embolic Agent: Basic Knowledge for Its Use in Interventional Neuroradiology.

Journal of neuroendovascular therapy

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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

Editorial - Philippe Ascher (1936-2022).

Neuroscience

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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

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PubMed • 2025

History of antineutrophil cytoplasmic autoantibodies : Milestones in rheumatology.

Zeitschrift fur Rheumatologie

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PubMed • 2025

A Hydrophilic Polyurethane Foam Containing Nigella sativa Oil as a Wound Dressing.

BioMed research international

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Frequently Asked Questions

What is sauflon clariti 1 day used for?

It is used for vision correction and UV protection as a daily disposable contact lens.

What specialties typically use this device?

Optometrists and ophthalmologists commonly use this device for patients needing vision correction.

What are the FDA-cleared indications?

The lens is indicated for vision correction of refractive errors and provides UV protection for daily wear.

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.

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