đź“‹ FDA Reference

esstech multi aspheric multifocal hioxifilcon b soft hydrophilic contact lens

Les Laboratoires Blanchard

Summary: The Esstech Multi Aspheric Multifocal Hioxifilcon B Soft Hydrophilic Contact Lens is a contact lens designed to correct presbyopia and other refractive errors. It is primarily used by optometrists and ophthalmologists for patients needing multifocal vision correction.

FDA Clearance Information

Pathway 510K
Decision Date September 1, 1998
Product Code LPL
Device Class Class 2
Evidence 419 studies

The device was cleared through the FDA 510(k) pathway on September 1, 1998. It is manufactured by Les Laboratoires Blanchard and classified as a Class 2 medical device under product code LPL.

What It Is

This device is a soft hydrophilic contact lens made from Hioxifilcon B, designed with a multi-aspheric multifocal structure. The lens provides vision correction for presbyopic patients by offering multiple focal points, allowing for clear vision at various distances. The hydrophilic nature of the lens ensures comfort and moisture retention, making it suitable for extended wear.

Clinical Applications

The Esstech Multi Aspheric Multifocal Lens is commonly used in optometry and ophthalmology practices for patients with presbyopia, a condition that typically affects individuals over the age of 40. It is also used to correct other refractive errors such as myopia or hyperopia in a multifocal format. The lens is particularly beneficial in outpatient settings where patients seek non-surgical options for vision correction.

Indications for Use

The FDA indications suggest this lens is intended for patients with presbyopia, a condition where the eye's lens loses flexibility, making it difficult to focus on close objects. It is suitable for patients who require correction for both near and distance vision.

Practical Considerations

These lenses are available in various sizes and prescriptions to accommodate different patient needs. They should be fitted by a professional to ensure proper alignment and comfort. Compatibility with the patient's tear film and ocular surface should be assessed to ensure optimal performance.

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

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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

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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

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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 the Esstech Multi Aspheric Multifocal Lens used for?

It is used for correcting presbyopia and other refractive errors by providing multifocal vision correction.

What specialties typically use this device?

Optometrists and ophthalmologists typically use this device in clinical settings.

What are the FDA-cleared indications?

The lens is indicated for patients with presbyopia and other refractive errors requiring multifocal 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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