đź“‹ FDA Reference
Sauflon 55 Uv Soft Hydrophilic Contact Lens
Sauflon Pharmaceuticals
Summary: The Sauflon 55 UV Soft Hydrophilic Contact Lens is a contact lens designed for vision correction and UV protection. It is used by optometrists and ophthalmologists for patients requiring vision correction.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K013649 ↗
Decision Date ?
December 26, 2001
Product Code ?
LPL
Device Class ?
Class 2
Evidence ?
419 studies
The Sauflon 55 UV Soft Hydrophilic Contact Lens was cleared through the FDA 510(k) pathway on December 26, 2001. It is manufactured by Sauflon Pharmaceuticals and classified as a Class 2 medical device.
What It Is
The Sauflon 55 UV Soft Hydrophilic Contact Lens is a soft contact lens made from hydrophilic material that retains moisture, providing comfort for the wearer. It features UV blocking properties to protect the eyes from harmful ultraviolet rays. This lens is designed to correct refractive errors such as myopia or hyperopia, offering clear vision and comfort for daily wear.
FDA-Cleared Indications
- Correction of refractive errors, including myopia and hyperopia, in patients who are appropriately fitted for soft contact lenses.
- Daily-wear use as prescribed by an eye-care professional.
- Use of a hydrophilic soft contact lens with UV-blocking properties.
Clinical Applications
- Vision correction for nearsightedness or farsightedness.
- Daily-wear contact lens use as an alternative to eyeglasses.
- Fitting patients with a soft hydrophilic contact lens in an optometry or ophthalmology setting.
- Use of UV-filtering contact lenses as part of routine vision correction.
Practical Considerations
- The lens must be prescribed and fitted by an optometrist or ophthalmologist; available parameters and sizes should be matched to the patient's prescription and ocular measurements.
- Patients should follow the prescribed wearing schedule and use only compatible cleaning, disinfecting and storage solutions.
- Hand hygiene, correct insertion and removal, and appropriate lens replacement are important to reduce the risk of infection and corneal injury.
- UV-blocking contact lenses do not replace sunglasses or other protection for the surrounding eye and eyelid skin.
- Contact lenses are generally not relevant to MRI safety because they are worn on the eye rather than implanted; patients should follow the imaging facility's instructions and remove lenses if requested.
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 the Sauflon 55 UV Soft Hydrophilic Contact Lens used for?
It is used for correcting refractive errors such as myopia or hyperopia and provides UV protection.
What specialties typically use this device?
Optometrists and ophthalmologists typically use this device for vision correction in patients.
What are the FDA-cleared indications?
The lens is indicated for vision correction in patients with refractive errors and offers 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.