đź“‹ FDA Reference
freshlook bifocal uv-absorbing phemfilcon a molded spherical handling tint and colored soft hydrophilic0 contact lens
Wesley Jessen
Summary: The FreshLook Bifocal UV-Absorbing Lens is a soft contact lens designed to correct presbyopia while offering UV protection. It is typically used by optometrists and ophthalmologists for patients needing both near and distance vision correction.
FDA Clearance Information
Pathway
510K
Number
K991550 ↗
Decision Date
May 14, 1999
Product Code
LPL
Device Class
Class 2
Evidence
419 studies
The FreshLook Bifocal UV-Absorbing Lens, manufactured by Wesley Jessen, was cleared through the FDA's 510(k) pathway on May 14, 1999. It is classified as a Class 2 medical device.
What It Is
The FreshLook Bifocal UV-Absorbing Lens is a soft, hydrophilic contact lens made from phemfilcon A. It features a bifocal design to aid in correcting presbyopia, a condition where the eye's lens loses flexibility, making it difficult to focus on close objects. The lens also absorbs UV light, providing additional eye protection from harmful UV rays. Its handling tint and color options enhance cosmetic appeal and ease of use.
Clinical Applications
This lens is commonly used in optometry and ophthalmology clinics for patients experiencing presbyopia, typically those over the age of 40. It is suitable for individuals who prefer contact lenses over bifocal glasses for aesthetic or lifestyle reasons. The lens is also beneficial in settings where UV protection is a priority, such as outdoor activities.
Indications for Use
The FDA indicates this lens for correcting presbyopia, a common age-related vision condition. It is suitable for patients requiring both near and distance vision correction, with the added benefit of UV protection.
Practical Considerations
The FreshLook Bifocal Lens comes in various sizes to fit different corneal curvatures. It is compatible with standard contact lens solutions for cleaning and storage. Clinicians should ensure proper fit and educate patients on insertion, removal, and care techniques.
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
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
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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
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 FreshLook Bifocal UV-Absorbing Lens used for?
It is used to correct presbyopia and provide UV protection for the eyes.
What specialties typically use this device?
Optometrists and ophthalmologists commonly use this lens for patients with presbyopia.
What are the FDA-cleared indications?
The lens is indicated for correcting presbyopia and providing 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.