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oti-05 lathe-40 polymacon lathe-cut hydrophili
Ocular Technologies
Summary: The oti-05 lathe-40 polymacon is a lathe-cut hydrophilic device used in ophthalmology. It is typically utilized by eye care specialists for various ocular procedures.
FDA Clearance Information
Pathway
PMA
Number
P890031 ↗
Decision Date
November 15, 1990
Product Code
LPL
Device Class
Class 2
Evidence
419 studies
The oti-05 lathe-40 polymacon, manufactured by Ocular Technologies, received FDA clearance via the PMA pathway on November 15, 1990. It is classified as a Class 2 medical device under product code LPL.
What It Is
The oti-05 lathe-40 polymacon is a hydrophilic device designed for use in ophthalmic procedures. It is lathe-cut, which suggests precision in its manufacturing process, making it suitable for delicate ocular applications. The polymacon material is known for its compatibility with the eye, providing a balance between durability and comfort.
Clinical Applications
This device is commonly used in ophthalmology, particularly in procedures involving the anterior segment of the eye. It may be employed in the fitting of contact lenses or other corrective ocular devices. Eye care specialists, including optometrists and ophthalmologists, utilize this device in both clinical and surgical settings, catering to a wide range of patient populations requiring vision correction or ocular surface management.
Indications for Use
The FDA indications suggest its use in procedures that require liquid embolization agents, although in this context, it is likely used for its hydrophilic properties in ocular applications. It is suitable for patients needing precise ocular device fitting or correction.
Practical Considerations
The device comes in various sizes to accommodate different ocular anatomies. It is compatible with standard ophthalmic equipment and requires careful handling due to its delicate nature. Clinicians should be familiar with lathe-cut techniques to ensure optimal outcomes.
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 oti-05 lathe-40 polymacon used for?
It is used in ophthalmic procedures, particularly for fitting contact lenses or other ocular devices.
What specialties typically use this device?
Ophthalmologists and optometrists commonly use this device in their practice.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring hydrophilic properties, typically in ocular applications.
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.