📋 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 ?
510(k)
Number ?
K982904 ↗
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.
FDA-Cleared Indications
- Correction of presbyopia with a multifocal soft hydrophilic contact lens
- Correction of refractive errors requiring multifocal vision correction, as specified by the prescription and labeling
Clinical Applications
- Multifocal correction of near and distance vision in patients with presbyopia
- Prescription vision correction for patients who also have myopia or hyperopia
- Fitting by an optometrist or ophthalmologist after assessment of refraction, ocular health and lens fit
- Non-surgical correction of presbyopic vision in an outpatient eye-care setting
Practical Considerations
- The lens should be selected and fitted by a qualified eye-care professional using the patient's prescription, corneal measurements and ocular health assessment.
- Available parameters may include different powers, base curves and diameters; the exact range depends on the cleared lens configuration and manufacturer specifications.
- The patient's tear film, corneal surface and tolerance for soft contact lenses should be assessed before fitting.
- Patients should follow the prescribed wearing, cleaning, replacement and storage schedule. Wearing time should not be extended beyond the eye-care professional's instructions.
- Contact lenses are not generally considered an MRI hazard because they contain no substantial ferromagnetic material, but the lens should be managed according to the imaging facility's instructions. The lens may need removal for the examination or for accurate ocular assessment.
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 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.