📋 FDA Reference
Frequency Uv Etafilcon a Hydrophilic Contact Lens for Daily Wear Clear and Tinted
Aspect Vision Care
Summary: The Frequency UV Etafilcon A Hydrophilic Contact Lens is designed for daily wear, available in clear and tinted options. It is primarily used by optometrists and ophthalmologists for vision correction.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K980634 ↗
Decision Date ?
April 22, 1998
Product Code ?
LPL
Device Class ?
Class 2
Evidence ?
419 studies
This device was cleared through the FDA 510(k) pathway on April 22, 1998, by Aspect Vision Care. It is classified as a Class 2 medical device under product code LPL.
What It Is
The Frequency UV Etafilcon A Hydrophilic Contact Lens is a soft contact lens made from etafilcon A, a hydrogel material. It is designed for daily wear to correct refractive errors such as myopia and hyperopia. The lens incorporates UV-blocking properties to protect the eyes from harmful ultraviolet rays. Available in both clear and tinted versions, it provides flexibility for cosmetic preferences.
FDA-Cleared Indications
- Daily-wear correction of refractive errors, including myopia and hyperopia.
- Use as a clear or tinted hydrophilic soft contact lens under the direction of an eye-care professional.
Clinical Applications
- Correction of nearsightedness (myopia).
- Correction of farsightedness (hyperopia).
- Daily wear as an alternative to eyeglasses for patients who require refractive vision correction.
- Use in clear or tinted lens configurations according to the prescribed lens and fitting parameters.
Practical Considerations
- The lens should be fitted and prescribed by a qualified optometrist or ophthalmologist.
- Patients should follow the prescribed wearing schedule, replacement instructions, cleaning procedures and hand-washing practices.
- The lens is intended for daily wear and should not be worn overnight unless specifically authorized by the prescribing eye-care professional.
- Available sizes and prescription parameters must match the patient's refraction, corneal shape and fitting requirements.
- Contact lenses are not evaluated as MRI devices; they should be managed according to the imaging center's instructions, particularly if the lens contains any tinted or cosmetic components.
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 Frequency UV Etafilcon A Hydrophilic Contact Lens used for?
It is used for correcting refractive errors such as myopia and hyperopia, and provides UV protection.
What specialties typically use this device?
Optometrists and ophthalmologists typically prescribe these contact lenses.
What are the FDA-cleared indications?
The lenses are indicated for daily wear to correct refractive errors and provide UV protection.
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.