đź“‹ FDA Reference
simulvue 38 polymacon soft hydrophilic bifocal contact lens
Unilens Corp., U
Summary: The simulvue 38 is a bifocal contact lens designed for vision correction in patients with presbyopia. It is used by optometrists and ophthalmologists to provide both near and distance vision correction.
FDA Clearance Information
Pathway
510K
Number
K942372 ↗
Decision Date
July 7, 1994
Product Code
LPL
Device Class
Class 2
Evidence
419 studies
The simulvue 38 bifocal contact lens was cleared through the FDA 510k pathway on July 7, 1994. Manufactured by Unilens Corp., U, it is classified as a Class 2 medical device.
What It Is
The simulvue 38 is a soft hydrophilic bifocal contact lens made from polymacon. It is designed to correct presbyopia by providing both near and distance vision in a single lens. The lens works by having different zones for near and far vision, allowing patients to see clearly at various distances without the need for separate reading glasses.
Clinical Applications
This bifocal contact lens is commonly used in optometry and ophthalmology practices for patients experiencing presbyopia, typically those over the age of 40. It is suitable for patients who prefer contact lenses over glasses for lifestyle or aesthetic reasons. The lens is used in routine eye care settings and can be fitted during regular eye exams.
Indications for Use
The FDA indications for the simulvue 38 lens are for the correction of presbyopia, a condition where the eye's lens loses flexibility, making it difficult to focus on close objects. It is intended for patients who require both near and distance vision correction.
Practical Considerations
The simulvue 38 lens is available in various sizes to fit different eye shapes and prescriptions. It is important to ensure proper fitting by a qualified eye care professional to maximize comfort and visual acuity. Patients should be instructed on proper lens care and hygiene to prevent infections.
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 simulvue 38 bifocal contact lens used for?
It is used for correcting presbyopia, providing both near and distance vision correction in a single lens.
What specialties typically use this device?
Optometrists and ophthalmologists typically use this device in their practices.
What are the FDA-cleared indications?
The lens is indicated for the correction of presbyopia, allowing patients to see clearly at both near and far distances.
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.