Device Information:
This Clariti 1 Day Multifocal (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker is made from somofilcon A, a silicone hydrogel co-polymer, and contains 56% water. The lens helps block harmful UV rays, absorbing 95% of UVB rays and 50% of UVA rays. It has a diameter of 13.0 to 15.5 mm and is available in various powers, including low, medium, and high reading additions.
Indications for Use:
The lens is indicated for daily wear and single use. It corrects myopia, hyperopia, and presbyopia in people with non-diseased eyes who may need up to +3.00 diopters for reading and have up to 1.50 diopters of astigmatism.
Intended Use:
The device is designed for use by individuals with non-diseased eyes who require optical correction for refractive ametropia (myopia, hyperopia) and presbyopia. It is intended for phakic or aphakic users.
Availability:
Prescription use only.
Study Results:
- Nonclinical and Safety Testing: The lens was tested following ISO standards for water content, dimensional, and optical parameters. The biocompatibility and performance results were deemed sufficient for substantial equivalence.
Regulatory Information:
- Regulation Number: 21 CFR 886.5925
- Regulatory Class: Class II
- Product Code: LPL, MVN
- 510(k) Number: K234127
The device complies with FDA regulations, including 21 CFR Part 820 for quality systems and Part 803 for medical device reporting. It is classified under Class II controls, requiring compliance with several FDA guidelines and performance standards.
Manufacturer Information:
- Name: CooperVision, Inc.
- Address: 6101 Bollinger Canyon Road, Suite 500, San Ramon, CA 94583
- Contact Person: Sahana Rajashekar
Predicate Device Information:
- Predicate Device Name: Clariti 1 Day Multifocal (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker
- 510(k) Number: K181920
- Differences: The subject device introduces a third ADD power range (Medium) while maintaining identical material and manufacturing methods.
Implications:
The device offers option for daily disposable contact lenses with UV protection. It can help people manage presbyopia, myopia, and hyperopia with added benefits of UV blocking.
References:
- Clariti 1 Day Multifocal (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker. 510(k) Number K234127. CooperVision, Inc.: FDA Summary: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?id=K234127
- CooperVision Manufacturer Website
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