CLEAR1-DAY Hioxifilcon Daily Disposable Soft Contact Lens
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K080632 FDA 510(k)
- FDA Product Code
- MVN FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 886.5925 FDA 510(k)
- Regulation Number
- 886.5925 FDA 510(k)
- Advisory Committee
- Ophthalmic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
This device is a daily disposable soft contact lens made from hioxifilcon A, a non-ionic copolymer of 2-HEMA and GMA. It functions as a refractive medium to focus light on the retina and is available in spherical, toric, and multifocal lens designs. The hydrophilic nature of the material allows the lens to become soft and pliable when immersed in an aqueous solution.
The lens is supplied as a single-use, sterile device intended for daily wear and disposal. It is manufactured via a spun-cast process and has received FDA 510(k) clearance under K080632, with a device class of II and product code MVN. The lens is regulated as an ophthalmic device and is not MRI conditional unless explicitly stated in the labeling.
Frequently asked questions
What is the CLEAR1-DAY HIOXIFILCON lens used for?
The CLEAR1-DAY HIOXIFILCON lens functions as a refractive medium to focus light on the retina, correcting vision for individuals with refractive errors such as myopia, hyperopia, astigmatism, or presbyopia, depending on the spherical, toric, or multifocal design selected.
How is the CLEAR1-DAY HIOXIFILCON lens supplied and is it sterile?
The lens is supplied as a single-use, sterile device, meaning each lens is individually packaged and sterilized to ensure it is free from microorganisms before use, reducing the risk of eye infection upon insertion.
Can the CLEAR1-DAY HIOXIFILCON lens be reused after removal?
No, the CLEAR1-DAY HIOXIFILCON lens is designed for daily disposable use only and must be discarded after each wearing; reusing it increases the risk of contamination, protein buildup, and corneal complications due to loss of sterility and material integrity.
What material is the CLEAR1-DAY HIOXIFILCON lens made from and how does it behave in solution?
The lens is made from hioxifilcon A, a non-ionic copolymer of 2-HEMA and GMA, which becomes soft and pliable when immersed in an aqueous solution due to its hydrophilic properties, allowing for comfortable wear and proper ocular surface interaction.
What regulatory pathway was used for the CLEAR1-DAY HIOXIFILCON lens?
The lens received FDA 510(k) clearance under submission number K080632, demonstrating substantial equivalence to a legally marketed predicate device, and is classified as a Class II medical device with product code MVN under ophthalmic device regulations.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF Clearlab SG Pte Ltd, Clear1-day Hioxifilcon Daily Disposable Soft Contact Lens (K080632 ..., PDF Clearlab SG Pte Ltd, Clear1-day Hioxifilcon Daily Disposable Soft Contact Lens
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K080632 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Clearlab Sg Pte. Ltd.
- FDA Applicant
- Clearlab SG Pte, Ltd.
Sources (1)
- FDA 510(k) K080632 24 fields · synced Sep 27, 2026