đź“‹ FDA Reference
prosoft phemfilcon soft hydrophilic contact lens
Wesley Jessen
Summary: The Prosoft Phemfilcon Soft Hydrophilic Contact Lens is a vision correction device used primarily by optometrists and ophthalmologists for patients requiring soft contact lenses. It's designed to provide comfort and clear vision for daily wear.
FDA Clearance Information
Pathway
510K
Number
K994335 ↗
Decision Date
March 20, 2000
Product Code
LPL
Device Class
Class 2
Evidence
419 studies
The Prosoft Phemfilcon Soft Hydrophilic Contact Lens was cleared by the FDA via the 510k pathway on March 20, 2000. It is manufactured by Wesley Jessen and classified as a Class 2 medical device.
What It Is
The Prosoft Phemfilcon Soft Hydrophilic Contact Lens is a soft, flexible lens made from a hydrophilic material known as phemfilcon. This material allows the lens to absorb water, making it comfortable for the wearer by maintaining moisture on the eye surface. The lens is designed for daily wear and provides vision correction for individuals with refractive errors such as myopia or hyperopia.
Clinical Applications
These lenses are commonly used in optometry and ophthalmology practices for patients who require vision correction but prefer contact lenses over glasses. They are suitable for a wide range of patients, including those with active lifestyles or those who find glasses inconvenient. The lenses are typically fitted and prescribed in outpatient settings by eye care professionals.
Indications for Use
The Prosoft Phemfilcon Soft Hydrophilic Contact Lens is indicated for patients needing vision correction due to refractive errors. It is suitable for individuals looking for a comfortable and convenient alternative to eyeglasses.
Practical Considerations
These lenses are available in various sizes and prescriptions to fit different eye shapes and vision needs. They are compatible with most standard contact lens solutions for cleaning and storage. Proper fitting by an eye care professional is essential to ensure comfort and effectiveness.
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 Prosoft Phemfilcon Soft Hydrophilic Contact Lens used for?
It is used for correcting vision in patients with refractive errors like myopia or hyperopia.
What specialties typically use this device?
Optometrists and ophthalmologists typically use this device in their practices.
What are the FDA-cleared indications?
The lens is indicated for vision correction in patients with refractive errors, providing a comfortable alternative to eyeglasses.
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.