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Pure Plus Uv Aspheric Otufilcon a Silicone Soft Hydrophilic Contact Lens for Daily Wear Daily Wear Pure Plus Uv Aspheric Otufilcon a 1-day Silicone Soft Hydrophilic Contact Lens Daily Disposable
Yung Sheng Optical
Summary: The Pure Plus UV Aspheric Otufilcon A is a daily disposable silicone soft hydrophilic contact lens designed for daily wear. It is primarily used by optometrists and ophthalmologists for patients requiring vision correction with added UV protection.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K244009 ↗
Decision Date ?
September 25, 2025
Product Code ?
LPL
Device Class ?
Class 2
Evidence ?
419 studies
This device was cleared through the FDA 510k pathway on September 25, 2025. Manufactured by Yung Sheng Optical, it is classified as a Class 2 medical device under product code LPL.
What It Is
The Pure Plus UV Aspheric Otufilcon A contact lens is a silicone-based, soft hydrophilic lens designed for daily wear and disposal. It incorporates UV-blocking technology to protect the eyes from harmful ultraviolet rays. The aspheric design helps to reduce spherical aberrations, providing clearer vision for users.
FDA-Cleared Indications
- Daily wear for the correction of refractive errors, including myopia and hyperopia.
- Single-use daily disposable wear; the lens is removed and discarded after each day.
- Use in eyes that meet the labeled fitting and prescription requirements for this contact lens.
Clinical Applications
- Correction of nearsightedness or farsightedness with a prescribed contact-lens power.
- Daily disposable contact-lens wear for patients who prefer a fresh lens each day.
- Vision correction with UV-blocking properties as an adjunct to, not a replacement for, sunglasses or other UV eye protection.
- Fitting and dispensing by an appropriately trained eye-care professional after evaluation of the eye and refractive prescription.
Practical Considerations
- The lens must be properly fitted and prescribed by an optometrist or ophthalmologist; available powers, base curves, diameters and other parameters depend on the FDA-cleared labeling.
- It is intended for daily wear, not overnight or extended wear. Remove and discard the lens at the end of the day rather than cleaning and reusing it.
- Wash and dry hands before handling. Do not use tap water, saliva or nonapproved solutions with the lens, and do not share contact lenses.
- UV filtering does not fully protect the eyes from sunlight; patients should continue to use appropriate sunglasses and other recommended eye protection.
- Patients with eye infection, active inflammation, significant ocular surface disease or other contact-lens contraindications should not wear the lens unless cleared by an eye-care professional. Discontinue use and seek evaluation for pain, redness, light sensitivity, discharge or sudden vision changes.
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 Pure Plus UV Aspheric Otufilcon A used for?
It is used for vision correction and provides UV protection, suitable for daily wear and disposal.
What specialties typically use this device?
Optometrists and ophthalmologists commonly use these lenses in clinical practice.
What are the FDA-cleared indications?
The lenses are indicated for daily wear to correct vision and provide UV protection.
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.