đź“‹ FDA Reference
Saview-Colors 42 Uv Hefilcon a Toric Hefilcon a Multifocal Hefilcon a Soft Hydrophilic Contact Lens
St. Shine Optical
Summary: The saview-colors 42 uv hefilcon a is a soft hydrophilic contact lens used for vision correction, available in toric and multifocal designs. It is primarily used by optometrists and ophthalmologists for patients requiring vision correction.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K123484 ↗
Decision Date ?
March 29, 2013
Product Code ?
LPL
Device Class ?
Class 2
Evidence ?
419 studies
This device was cleared through the FDA 510(k) pathway on March 29, 2013, by St. Shine Optical. It is classified as a Class 2 medical device under product code LPL.
What It Is
The saview-colors 42 uv hefilcon a is a soft contact lens made from hefilcon A, a hydrophilic material that allows for comfort and extended wear. It is available in toric and multifocal designs, catering to patients with astigmatism and presbyopia, respectively. The lens also offers UV protection, making it suitable for daily wear in various lighting conditions.
FDA-Cleared Indications
- Vision correction with a soft hydrophilic contact lens.
- Correction of astigmatism with the toric lens design.
- Correction of presbyopia with the multifocal lens design.
Clinical Applications
- Prescribed contact-lens correction for refractive error.
- Toric contact-lens correction for patients with astigmatism.
- Multifocal contact-lens correction for patients with presbyopia.
- Fitting and dispensing by an eye-care professional after evaluation of the patient's eyes and prescription.
Practical Considerations
- The lens must be fitted and prescribed by an optometrist or ophthalmologist; the correct base curve, diameter, power and design depend on the patient's examination.
- Follow the prescribed wearing schedule and the manufacturer's instructions for cleaning, disinfection, storage and replacement.
- Do not use tap water, saliva or non-approved solutions to clean or store the lens. Poor hygiene increases the risk of corneal infection.
- Patients with active eye infection, significant ocular inflammation or other contraindications to contact-lens wear may not be appropriate candidates.
- Contact lenses are not evaluated as implantable devices and are not relevant to MRI safety. Remove them if instructed during an eye or medical examination.
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 42 uv hefilcon a used for?
It is used for vision correction in patients with astigmatism and presbyopia, providing clear and comfortable vision.
What specialties typically use this device?
Optometrists and ophthalmologists typically use these contact lenses in their practice.
What are the FDA-cleared indications?
The lenses are indicated for correcting refractive errors such as astigmatism and presbyopia, offering clear vision and 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.