Gelflex (Dimefilcon A) Contact Lens
by Dow Corning Ophthalmics, Inc.
PMA N17722
Active
Valid until
No expiry
FDA recalls
None foundDocuments
PMA N17722
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberN17722 | Date21 Aug 1979 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Full name
- Gelflex(R) (Dimefilcon a) Contact Lens
- 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
- S002
Overview
AI-generated summary, 18 Sep 2026
This device is a soft contact lens designed for daily wear, classified under the nomenclature ‘Lenses, soft contact, daily wear.’ Manufactured from dimefilcon A, a silicone hydrogel material, it is intended for corneal refractive correction and vision enhancement in compliant users. The lens is engineered to provide clear vision while maintaining comfort over extended periods of daily use.
The Gelflex (Dimefilcon A) Contact Lens is supplied as a single-use or disposable product, intended for sterile application to the eye. It is regulated under FDA Premarket Approval (PMA N17722) and falls under product code LPL, adhering to regulation 886.5925. Available in various sizes and curvatures, the lens requires proper handling and storage in a clean, dry environment to preserve sterility and functionality. No MRI safety data is specified.
Questions
AI-generated answers, 18 Sep 2026
What is the primary purpose of the GELFLEX® (Dimefilcon A) Contact Lens, and who is it designed for?
The GELFLEX® (Dimefilcon A) Contact Lens is designed for corneal refractive correction and vision enhancement in compliant users. It is a soft contact lens made from silicone hydrogel material (dimefilcon A), intended for daily wear to provide clear vision while maintaining comfort over extended periods.
Is the GELFLEX® (Dimefilcon A) Contact Lens single-use or reusable, and how should it be stored?
The GELFLEX® (Dimefilcon A) Contact Lens is supplied as a single-use or disposable product, meaning each lens is intended for one-time use before disposal. To preserve sterility and functionality, it must be stored in a clean, dry environment and handled carefully before application.
What regulatory pathway does the GELFLEX® (Dimefilcon A) Contact Lens follow, and what does that mean for its use?
The GELFLEX® (Dimefilcon A) Contact Lens is regulated under FDA Premarket Approval (PMA N17722), meaning it has undergone rigorous review to ensure safety and effectiveness. This approval covers its use as a daily-wear soft contact lens for refractive correction, but it does not imply any specific clinical indication beyond what is stated in the approved labeling.
Are there different sizes or curvatures available for the GELFLEX® (Dimefilcon A) Contact Lens, and how does that affect fitting?
Yes, the GELFLEX® (Dimefilcon A) Contact Lens is available in various sizes and curvatures to accommodate different corneal shapes and prescription needs. Proper fitting is essential for comfort and vision clarity, so these variations allow for customization based on the user’s specific ocular requirements.
Can the GELFLEX® (Dimefilcon A) Contact Lens be used safely in an MRI environment, and why?
The device data does not specify MRI safety information, meaning there is no confirmed guidance on whether the GELFLEX® (Dimefilcon A) Contact Lens can be safely used during MRI procedures. Users should consult the manufacturer or clinical guidelines before use in an MRI setting to avoid potential risks.