Melafocon A/Rigid Gas Perm Contact Len for Daily Wear
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K943784 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)
This device is a rigid gas permeable contact lens intended for daily wear. It is designed to be worn directly against the cornea of the eye to correct vision conditions. The lens is made of materials such as cellulose acetate butyrate, polyacrylate-silicone, or silicone elastomers, whose main polymer molecules generally do not absorb or attract water.
It is supplied as a reusable device for daily wear and is classified as FDA Class 2 under product code HQD. The device received FDA 510(k) clearance (K943784) on October 20, 1994, and is substantially equivalent to a legally marketed device. It is regulated under regulation number 886.5916 and falls within the ophthalmic medical specialty.
Frequently asked questions
What is the MELAFOCON A contact lens used for?
The MELAFOCON A is a rigid gas permeable contact lens designed to be worn directly against the cornea to correct vision conditions during daily wear. It is intended for refractive error correction and is not indicated for therapeutic or medicinal purposes beyond vision correction.
Is the MELAFOCON A contact lens reusable or single-use?
The MELAFOCON A is supplied as a reusable device for daily wear, meaning it is designed to be removed, cleaned, and reinserted each day rather than discarded after a single use. Reusability depends on proper lens care and adherence to the manufacturer’s recommended replacement schedule.
What materials is the MELAFOCON A contact lens made from?
The lens is made of materials such as cellulose acetate butyrate, polyacrylate-silicone, or silicone elastomers, whose main polymer molecules generally do not absorb or attract water. These materials are chosen for their oxygen permeability and stability on the eye.
How was the MELAFOCON A contact lens cleared for market?
The MELAFOCON A received FDA 510(k) clearance (K943784) on October 20, 1994, as substantially equivalent to a legally marketed device. It is classified as FDA Class 2 under product code HQD and regulated under 21 CFR 886.5916.
What regulatory classification and product code apply to the MELAFOCON A?
The MELAFOCON A is classified as FDA Class 2 and assigned product code HQD, which corresponds to 'Lens, Contact (Other Material) - Daily.' It falls under regulation number 886.5916 and is part of the ophthalmic medical specialty.
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: Melafocon A/Rigid Gas Perm Contact Len for Daily Wear, Melafocon A/Rigid Gas Perm Contact Len for Daily Wear, Melafocon A/Rigid Gas Perm Contact Len for Daily Wear, fda.innolitics.com, www.accessdata.fda.gov
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K943784 | Class II | Active |
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Manufacturer
- Manufacturer
- Menicon Co., Ltd.
- FDA Applicant
- Menicon Co, Ltd.
Sources (1)
- FDA 510(k) K943784 24 fields · synced Sep 28, 2026