Identifiers
- 510(k) Number
- K944223 FDA 510(k)
- FDA Product Code
- HQD FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 886.5916 FDA 510(k)
- Regulation Number
- 886.5916 FDA 510(k)
- Advisory Committee
- Ophthalmic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Accucon Contact Lens is a daily-wear, single-use contact lens designed for ophthalmic use. Classified as a contact lens made from other materials, it is intended for correction or enhancement of vision without the need for daily removal. This device falls under the category of daily disposable contact lenses, ensuring convenience and hygiene for users.
Accucon lenses are supplied as single-use, non-sterile products intended for one-time application per lens. They are regulated under FDA 510(k) clearance (K944223) and fall under device class II. The lenses are not intended for MRI use and must be stored in a clean, dry environment as per manufacturer guidelines. No additional regulatory approvals beyond the 510(k) clearance are stated.
Frequently asked questions
What is the Accucon Contact Lens designed for?
The Accucon Contact Lens is specifically designed for ophthalmic use to correct or enhance vision on a daily basis. As a daily-wear, single-use lens, it eliminates the need for daily removal, making it ideal for users seeking convenience and maintaining hygiene without the hassle of cleaning or storing lenses.
How is the Accucon Contact Lens supplied, and is it sterile?
The Accucon Contact Lens is supplied as a single-use, non-sterile product. Each lens is intended for one-time application only, ensuring convenience but requiring users to follow proper hygiene practices before insertion. The non-sterile nature means it is not pre-sterilized and must be handled in a clean environment.
Are Accucon lenses reusable, and if not, how should they be disposed of?
No, Accucon lenses are strictly single-use and not intended for reuse. After one application, they should be discarded properly to maintain hygiene and prevent contamination. Users should follow local waste disposal guidelines for medical devices.
What storage conditions are required for Accucon lenses?
Accucon lenses must be stored in a clean, dry environment to preserve their integrity. Avoid exposure to moisture, direct sunlight, or extreme temperatures, as these conditions can compromise the lens material or affect its performance.
What regulatory clearance does the Accucon Contact Lens hold?
The Accucon Contact Lens holds FDA 510(k) clearance under the reference number K944223. This clearance indicates that the device is classified as substantially equivalent to a legally marketed predicate device and falls under FDA device class II, which includes contact lenses made from other materials.
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: ACCUCON Trademark | Bizapedia, ACCUCON Trademark of Innovision, Inc. - Registration Number 4850049 ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K944223 | Class II | Active |
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Manufacturer
- Manufacturer
- Innovision, Inc
- FDA Applicant
- Innovision, Inc.
Sources (1)
- FDA 510(k) K944223 24 fields · synced Oct 1, 2026