đź“‹ FDA Reference
saview-colors aqua 42 uv hefilcon a soft hydrophilic contact lens saview-colors aqua 42 uv toric hefilcon a soft hydrophilic contact lens saview-colors aqua 42 uv multifocal hefilcon a soft hydrophilic contact lens
St. Shine Optical
Summary: Saview-Colors Aqua 42 UV contact lenses are soft hydrophilic lenses used for vision correction. They are available in toric and multifocal designs, suitable for patients with astigmatism or presbyopia.
FDA Clearance Information
Pathway
510K
Number
K162317 ↗
Decision Date
October 21, 2016
Product Code
LPL
Device Class
Class 2
Evidence
419 studies
The Saview-Colors Aqua 42 UV contact lenses by St. Shine Optical were cleared via the FDA 510k pathway on October 21, 2016. These Class 2 medical devices are designed for vision correction.
What It Is
The Saview-Colors Aqua 42 UV contact lenses are soft, hydrophilic lenses made from hefilcon A material. They are designed to correct refractive errors such as astigmatism and presbyopia, offering both toric and multifocal options. The lenses incorporate UV protection, enhancing eye safety by blocking harmful ultraviolet rays.
Clinical Applications
These lenses are commonly used in optometry and ophthalmology practices for patients requiring vision correction. They are suitable for individuals with astigmatism, presbyopia, or those who prefer colored lenses for aesthetic purposes. The lenses are typically fitted in outpatient settings, including eye clinics and optical retail stores.
Indications for Use
The lenses are indicated for patients needing correction for astigmatism or presbyopia. They are also suitable for those seeking UV protection and colored lens options for cosmetic enhancement.
Practical Considerations
These lenses are available in various prescriptions to accommodate different levels of refractive error. Clinicians should ensure proper fitting to maximize comfort and visual acuity. Compatibility with standard contact lens solutions is expected, but patients should be advised on proper lens care and hygiene.
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 Saview-Colors Aqua 42 UV contact lens used for?
These lenses are used for correcting vision issues such as astigmatism and presbyopia, and they offer UV protection.
What specialties typically use this device?
Optometrists and ophthalmologists commonly use these lenses in their practices for vision correction.
What are the FDA-cleared indications?
The lenses are indicated for correcting astigmatism and presbyopia, with added UV protection and cosmetic color options.
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.