Menicon Soft Contact Lenses
by N&N Menicon, Inc. PMA
Active
PMA P800031
Overview
Menicon Soft Contact Lenses are daily-wear, disposable soft contact lenses designed for vision correction. These lenses are classified as Class II medical devices and are intended for ophthalmic use, providing clear and comfortable vision for extended periods while adhering to the standards for soft contact lenses as defined by regulatory authorities.
These lenses are supplied as single-use, non-reusable products intended for daily wear and are not intended for overnight use. They are regulated under FDA Premarket Approval (PMA) with the approval number P800031 and are distributed under the trade name (MAFILCON). The lenses are packaged and stored in sterile conditions, adhering to strict manufacturing and regulatory guidelines to ensure safety and efficacy for the intended use.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP800031 | Date5 May 1989 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA PMA Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- Full name
- (Mafilcon) Soft Contact Lenses
- Generic Name
- Lenses, soft contact, daily wear
- PMA Number
- FDA Product Code
- LPL
- Device Class
- Class II
- Regulation
- 21 CFR Part 886.5925
- Advisory Committee
- Ophthalmic
- FDA Decision
- APPR Approved
- PMA Supplement
- S001 (Normal 180 Day Track)
Questions
What are the Menicon Soft Contact Lenses designed for?
These lenses are designed for vision correction as daily-wear, disposable soft contact lenses, providing clear and comfortable vision for extended periods while adhering to regulatory standards for soft contact lenses.
How are the Menicon Soft Contact Lenses supplied and can they be reused?
The lenses are supplied as single-use, non-reusable products intended for daily wear only and are not designed for overnight use, ensuring safety and efficacy for their intended purpose.
What is the regulatory status of the Menicon Soft Contact Lenses?
These lenses are regulated under FDA Premarket Approval (PMA) with approval number P800031, classified as Class II medical devices for ophthalmic use, and distributed under the trade name (MAFILCON).
How are the Menicon Soft Contact Lenses packaged and stored?
The lenses are packaged and stored in sterile conditions, adhering to strict manufacturing and regulatory guidelines to ensure safety and efficacy for the intended ophthalmic use.