📋 FDA Reference
Gelflex Delta 55 Methafilcon a Hydrophilic Contact Lens
Gelflex Laboratories
Summary: The Gelflex Delta 55 Methafilcon A is a hydrophilic contact lens used primarily for vision correction. It is designed for individuals requiring corrective lenses and is typically used by optometrists and ophthalmologists.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K962710 ↗
Decision Date ?
September 5, 1996
Product Code ?
LPL
Device Class ?
Class 2
Evidence ?
419 studies
The Gelflex Delta 55 Methafilcon A contact lens was cleared through the FDA's 510(k) pathway on September 5, 1996. It is manufactured by Gelflex Laboratories and classified as a Class 2 medical device.
What It Is
The Gelflex Delta 55 Methafilcon A is a soft, hydrophilic contact lens made from methafilcon A, a material known for its water-retaining properties. This lens is designed to provide comfort and clear vision for individuals with refractive errors such as myopia or hyperopia. The lens's hydrophilic nature helps maintain moisture, reducing dryness and discomfort for the wearer.
FDA-Cleared Indications
- Correction of refractive errors, including nearsightedness and farsightedness.
- Daily wear by patients who require contact-lens vision correction.
Clinical Applications
- Daily-wear correction of myopia, or nearsightedness.
- Daily-wear correction of hyperopia, or farsightedness.
- Prescription contact-lens fitting after an eye examination.
- Vision correction for patients who prefer contact lenses instead of spectacles.
Practical Considerations
- The lens must be selected and fitted by an optometrist or ophthalmologist; available parameters may include different powers, diameters and base curves.
- Patients should follow the prescribed wearing schedule and use the recommended cleaning, disinfecting and storage system.
- The lens should not be shared, worn beyond its replacement schedule or exposed to water, including tap water and swimming water.
- Patients with active eye infection, significant ocular inflammation or an inability to maintain lens hygiene may not be appropriate candidates.
- This is a contact lens, not an implanted device; MRI compatibility is generally not a relevant safety issue when the lens is worn, but patients should follow the imaging facility's 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 Gelflex Delta 55 Methafilcon A used for?
It is used for correcting refractive errors like myopia and hyperopia in patients who prefer contact lenses over glasses.
What specialties typically use this device?
Optometrists and ophthalmologists typically use this device in clinical settings for vision correction.
What are the FDA-cleared indications?
The device is indicated for the correction of refractive errors such as nearsightedness and farsightedness in individuals requiring vision correction.
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.