Contaflex GM3 58% (Acofilcon A) Spherical Soft Contact Lens for Daily Wear (Clear and Tinted, Lathe-Cut)
510(k) K023349
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK023349 | Date24 Dec 2002 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- LPL
- Device Class
- Class II
- Regulation
- 21 CFR Part 886.5925
- Advisory Committee
- Ophthalmic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Contaflex GM3 58% (Acofilcon A) Spherical Soft Contact Lens is a daily-wear soft contact lens designed for optical correction. It is manufactured from Acofilcon A, a silicone hydrogel material with a water content of 58%, providing clear vision while maintaining comfort for extended use. Available in clear and tinted variants, these lenses are lathe-cut for precision fitting and are intended for short-term wear during the day.
These lenses are supplied sterile and intended for single-use per day. They are classified as Class II medical devices under FDA regulations and have received 510(k) clearance for marketing in the United States. The lenses are supplied in individual blister packs and require proper storage as directed by the manufacturer to maintain sterility and performance. No MRI safety information or reusable specifications are indicated for this product.
Other devices from Contamac, Ltd.
Questions
AI-generated answers, 1 Oct 2026
What is the Contaflex GM3 58% (Acofilcon A) Spherical Soft Contact Lens used for?
This lens is designed for optical correction, providing clear vision during daily wear. The silicone hydrogel material (Acofilcon A) with 58% water content ensures comfort and moisture retention, making it suitable for extended daytime use. It is available in both clear and tinted variants to accommodate different preferences or aesthetic needs.
How is the Contaflex GM3 58% lens supplied, and is it sterile?
The lenses are supplied individually in sterile blister packs, ensuring sterility upon opening. Each lens is intended for single-use per day, which helps maintain hygiene and reduce the risk of infection. Proper storage as directed by the manufacturer is required to preserve sterility and performance.
Are these lenses reusable, or are they meant for single-use?
These lenses are explicitly designed for single-use per day. The manufacturer emphasizes this to ensure optimal hygiene and safety, as reusable contact lenses carry a higher risk of contamination and eye irritation over time.
What materials are used in the Contaflex GM3 58% lens, and how does that affect comfort?
The lens is made from Acofilcon A, a silicone hydrogel material with 58% water content. Silicone hydrogel materials are known for their oxygen permeability, which allows for better oxygen flow to the eye compared to traditional hydrogel lenses. This design enhances comfort, especially during extended wear, while maintaining clarity and moisture retention.
How should these lenses be stored to maintain their integrity?
The lenses must be stored according to the manufacturer’s instructions to preserve sterility and performance. Since they are single-use, they should remain in their sealed blister pack until use. After opening, the lens should be handled with clean, dry hands, and any unused lenses should be discarded to avoid contamination.