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tangible hydrogel w hydra-peg etafilcon a soft hydrophilic daily wear contact lens
Tangible Science
Summary: The Tangible Hydrogel with Hydra-PEG Etafilcon A is a soft hydrophilic daily wear contact lens designed for vision correction. It is used by optometrists and ophthalmologists to improve visual acuity in patients requiring contact lenses.
FDA Clearance Information
Pathway
510K
Number
K171125 ↗
Decision Date
October 18, 2017
Product Code
LPL
Device Class
Class 2
Evidence
419 studies
The device was cleared through the FDA 510(k) pathway on October 18, 2017, by Tangible Science. It is classified as a Class 2 medical device under product code LPL.
What It Is
This device is a daily wear contact lens made from etafilcon A, a soft hydrophilic material. It features a Hydra-PEG coating that enhances lens wettability and comfort by retaining moisture on the lens surface. This makes it particularly beneficial for patients with dry eyes or those who experience discomfort with traditional contact lenses.
Clinical Applications
The Tangible Hydrogel lens is commonly used in optometry and ophthalmology clinics for patients who require vision correction but prefer contact lenses over glasses. It is suitable for a wide range of refractive errors, including myopia and hyperopia. The lens is particularly advantageous in settings where patients experience dry eye symptoms, as the Hydra-PEG coating provides additional comfort.
Indications for Use
The FDA-cleared indications suggest this lens is intended for patients needing vision correction through contact lenses. It is particularly useful for those who experience discomfort with regular lenses due to dry eyes.
Practical Considerations
These lenses are typically available in a variety of sizes to fit different corneal shapes. They are compatible with standard contact lens fitting techniques. Clinicians should ensure proper lens hygiene and educate patients on daily lens care to maximize comfort and lens lifespan.
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 Tangible Hydrogel w Hydra-PEG Etafilcon A Lens used for?
It is used for vision correction in patients who prefer contact lenses, especially those with dry eyes.
What specialties typically use this device?
Optometrists and ophthalmologists commonly use this device in clinical practice.
What are the FDA-cleared indications?
The lens is indicated for vision correction in patients needing contact lenses, particularly those experiencing discomfort with traditional lenses due to dry eyes.
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.