đź“‹ FDA Reference

saview-aqua 58 uv etafilcon a visibility tinted soft hydrophilic contact lens saview-aqua 58 uv toric etafilcon a

St. Shine Optical

Summary: The saview-aqua 58 UV etafilcon a contact lens is a soft hydrophilic lens designed to provide UV protection. It is used by eye care professionals to help protect patients' eyes from harmful UV radiation.

FDA Clearance Information

Pathway 510K
Decision Date August 30, 2013
Product Code LPL
Device Class Class 2
Evidence 419 studies

The saview-aqua 58 UV contact lens by St. Shine Optical was cleared through the FDA 510k pathway on August 30, 2013. It is a Class 2 medical device.

What It Is

The saview-aqua 58 UV etafilcon a contact lens is a soft, hydrophilic lens with UV-blocking properties. Made from etafilcon a, it is designed to fit comfortably on the eye while providing protection against harmful ultraviolet radiation. The lens is visibility tinted to aid in handling and is available in toric designs for patients with astigmatism.

Clinical Applications

These lenses are commonly used in optometry and ophthalmology settings to protect patients' eyes from UV radiation, which can contribute to conditions like cataracts and pterygium. They are particularly useful for patients who spend significant time outdoors or in environments with high UV exposure. The lenses can be prescribed for daily wear by patients with refractive errors, including those with astigmatism.

Indications for Use

The FDA indications suggest that these lenses are intended for vision correction while providing additional UV protection. They are suitable for patients needing refractive correction and seeking to minimize UV exposure to the eyes.

Practical Considerations

These lenses are typically available in a range of prescriptions to accommodate different refractive errors. They are designed for daily wear and should be replaced according to the manufacturer's guidelines. Proper handling and cleaning techniques are essential to maintain lens integrity and ocular health.

Related Literature

The linked study investigated the UV radiation protection factors of hydrogel and silicone hydrogel contact lenses. It highlighted that UV-blocking lenses can protect the anterior ocular tissues, particularly in the limbal region, from UV-induced damage. The study emphasized the importance of lens thickness in determining UV protection efficacy but did not address long-term clinical outcomes.

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

Editorial - Philippe Ascher (1936-2022).

Neuroscience

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 saview-aqua 58 UV contact lens used for?

It is used for vision correction and to protect the eyes from harmful UV radiation.

What specialties typically use this device?

Optometrists and ophthalmologists commonly prescribe these lenses.

What are the FDA-cleared indications?

The lenses are indicated for vision correction and UV protection in patients requiring refractive 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.

📬 Stay Updated

Get the latest vascular education content delivered to your inbox.