📋 FDA Reference
Lifestyle Frequency Progressive Methafilcon a Multifocal Hydrophilic Contact Lenses for Daily Wear
Permeable Technologies
Summary: The lifestyle frequency progressive methafilcon A multifocal hydrophilic contact lenses are designed for daily wear to correct vision in patients with presbyopia. They are used by optometrists and ophthalmologists to provide a non-surgical solution for age-related vision changes.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K963011 ↗
Decision Date ?
November 29, 1996
Product Code ?
LPL
Device Class ?
Class 2
Evidence ?
419 studies
This device was cleared through the FDA 510(k) pathway on November 29, 1996, by Permeable Technologies. It is classified as a Class 2 medical device under product code LPL.
What It Is
These contact lenses are made from methafilcon A, a hydrophilic material that allows oxygen to pass through to the cornea, maintaining eye health during wear. They feature a multifocal design to provide clear vision at multiple distances, addressing the needs of patients with presbyopia. The lenses are intended for daily wear, offering a convenient and non-invasive option for vision correction.
FDA-Cleared Indications
- Daily-wear correction of refractive errors in patients with presbyopia.
- Multifocal contact-lens correction for adults who need vision correction at more than one distance.
Clinical Applications
- Correction of presbyopia with a multifocal soft contact lens.
- Daily-wear vision correction for patients who need near, intermediate and distance vision.
- Outpatient contact-lens fitting and follow-up by an optometrist or ophthalmologist.
Practical Considerations
- The lenses require fitting and prescription by a qualified eye-care professional; base curve, diameter and lens power must match the patient's eye.
- Patients should follow recommended cleaning, disinfection, replacement and wearing schedules to reduce the risk of corneal infection and other complications.
- The lenses are intended for daily wear and should not be worn overnight unless specifically authorized by the prescribing clinician.
- They are not implanted devices and are not evaluated for MRI compatibility; because they are worn on the eye, they should generally be removed before MRI unless the eye-care and imaging teams advise otherwise.
- Use may be unsuitable for patients with active eye infection, significant ocular inflammation, severe dry eye or an inability to follow lens-hygiene instructions.
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 lifestyle frequency progressive methafilcon a multifocal hydrophilic contact lenses used for?
These lenses are used for correcting presbyopia, providing clear vision at multiple distances for daily wear.
What specialties typically use this device?
Optometrists and ophthalmologists typically use these lenses in their practice for patients requiring vision correction for presbyopia.
What are the FDA-cleared indications?
The lenses are indicated for the correction of refractive errors in patients with presbyopia, allowing for clear vision at multiple distances.
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.