📋 FDA Reference
Dream Color I Polymacon Soft Hydrophilic Contact Lens Dream Color II Polymacon Soft Hydrophilic Contact Lens D
Dreamcon
Summary: The Dream Color I and II are polymacon soft hydrophilic contact lenses used for vision correction. They are typically used by optometrists and ophthalmologists for patients requiring corrective lenses.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K123431 ↗
Decision Date ?
June 17, 2013
Product Code ?
LPL
Device Class ?
Class 2
Evidence ?
419 studies
The Dream Color I and II lenses were cleared through the FDA 510k pathway on June 17, 2013. Manufactured by Dreamcon, these devices are classified as Class 2 under product code LPL.
What It Is
The Dream Color I and II are soft contact lenses made from polymacon, a hydrophilic material that retains moisture, enhancing comfort for the wearer. These lenses are designed to correct refractive errors such as myopia or hyperopia. They are available in various colors, allowing for both vision correction and cosmetic enhancement.
FDA-Cleared Indications
- Correction of myopia (nearsightedness).
- Correction of hyperopia (farsightedness).
- Use as prescribed and fitted by an eye-care professional for vision correction.
Clinical Applications
- Daily vision correction for patients with myopia.
- Daily vision correction for patients with hyperopia.
- Use as an alternative to eyeglasses when a properly fitted contact lens is appropriate.
- Use of tinted or colored lens options for cosmetic enhancement while providing refractive correction.
Practical Considerations
- A licensed eye-care professional must determine the prescription, base curve, diameter and fit; available dimensions may vary by lens model and prescription.
- Follow the prescribed wearing schedule and use only the recommended cleaning, disinfecting and storage solutions.
- Do not share contact lenses, sleep in them unless specifically directed, or use them with nonsterile water.
- Contact lenses are not evaluated for MRI safety in the same way as implanted devices; ask the imaging facility whether lenses should be removed before an MRI.
- Patients with active eye infection, significant eye inflammation or an inability to follow lens-care instructions may not be appropriate candidates.
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 Dream Color I & II used for?
These lenses are used for correcting refractive errors like myopia and hyperopia, and they also offer cosmetic color options.
What specialties typically use this device?
Optometrists and ophthalmologists typically prescribe these lenses for vision correction.
What are the FDA-cleared indications?
These lenses are indicated for correcting refractive errors such as nearsightedness and farsightedness.
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.