đź“‹ FDA Reference

specialty 55 multifocal methafilcon a soft hydrophilic contact lenses for daily wear

Clearlab Pte

Summary: The Specialty 55 Multifocal Methafilcon A Soft Hydrophilic Contact Lenses are designed for daily wear to correct vision in patients with presbyopia. They are primarily used by optometrists and ophthalmologists.

FDA Clearance Information

Pathway 510K
Decision Date February 13, 2001
Product Code LPL
Device Class Class 2
Evidence 419 studies

The Specialty 55 Multifocal Contact Lenses were cleared through the FDA 510(k) pathway on February 13, 2001. Manufactured by Clearlab Pte, they are classified as Class 2 medical devices under product code LPL.

What It Is

These lenses are soft hydrophilic contact lenses made from methafilcon A, designed for daily wear. They incorporate multifocal technology, allowing for the correction of presbyopia by providing multiple focal points. This design helps users see clearly at various distances, enhancing visual acuity for near, intermediate, and far vision.

Clinical Applications

These lenses are commonly used in optometry and ophthalmology clinics for patients experiencing presbyopia, typically those over the age of 40. They are suitable for individuals who prefer contact lenses over glasses for vision correction. The lenses are used in routine eye care settings and are fitted by eye care professionals to ensure optimal vision correction and comfort.

Indications for Use

The lenses are indicated for patients with presbyopia, a condition where the eye's lens loses flexibility, making it difficult to focus on close objects. These lenses help correct this condition by providing multifocal vision correction.

Practical Considerations

These lenses are available in various sizes to fit different corneal shapes and are compatible with standard contact lens care solutions. Proper fitting by an eye care professional is essential to ensure comfort and effective vision correction.

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

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PubMed • 2025

Clinical progress note: Haemophilus influenzae type b.

Journal of hospital medicine

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PubMed • 2025

Pilot study of social media promotion of home-based self-testing for syphilis.

Sexually transmitted diseases

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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

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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

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PubMed • 2025

Tp40: a new potential prognostic and diagnostic marker for syphilis.

Microbiology spectrum

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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

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PubMed • 2025

Editorial - Philippe Ascher (1936-2022).

Neuroscience

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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

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Frequently Asked Questions

What is Specialty 55 Multifocal Contact Lenses used for?

They are used to correct 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.

What are the FDA-cleared indications?

The lenses are indicated for the correction of presbyopia in patients requiring multifocal 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.

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