Largan U38 Color (Polymacon) Daily Wear Soft Contact Lens
510(k) K242916
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK242916 | Date4 Feb 2025 | 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- Withdrawn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
- Full name
- Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens
- 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, 19 Sep 2026
The Largan U38 Color (Polymacon) Daily Wear Soft Contact Lens is a Soft Contact Lens, Daily Wear (as classified by FDA regulation 886.5925). It is designed as an aspherical, hydrophilic contact lens made from Polymacon, a hydrogel copolymer composed of 2-Hydroxyethyl methacrylate (HEMA) and Ethylene Glycol Dimethacrylate (EGDMA). This material provides oxygen permeability to support corneal health during wear.
Intended for single-use daily wear, this lens is supplied sterile and requires no reprocessing. It is classified as Class II under FDA regulations and has received FDA 510(k) clearance (K242916) as substantially equivalent. The product code is LPL, and it adheres to ophthalmic standards for daily disposable contact lenses. No MRI safety or reusable specifications are noted in the regulatory data.
Other devices from Largan Medical Co., Ltd.
Questions
AI-generated answers, 19 Sep 2026
What is the primary material used in the Largan U38 Color (Polymacon) Daily Wear Soft Contact Lens, and why is it significant for corneal health?
The lens is made from Polymacon, a hydrogel copolymer combining 2-Hydroxyethyl methacrylate (HEMA) and Ethylene Glycol Dimethacrylate (EGDMA). This material is significant because it provides oxygen permeability, which supports corneal health during extended wear by allowing adequate oxygen flow to the eye.
Are these lenses intended for single-use or reusable, and what does that mean for maintenance?
The Largan U38 Color lenses are intended for single-use daily wear, meaning each lens is designed for one day of use and must not be reused. Since they are supplied sterile, no reprocessing or cleaning is required, reducing the risk of contamination or damage.
How many different sizes or models of this lens are available, and how would I know which one fits my prescription?
The data lists multiple registration numbers (e.g., 3015533540, 3012546757, etc.), which correspond to different base curve and diameter combinations for the lens. These variations allow for customization to fit various prescriptions. A healthcare provider would determine the correct size based on your eye’s specific measurements and needs.
Can these lenses be used safely in an MRI, or are there any restrictions?
The regulatory data does not mention MRI safety for the Largan U38 Color lenses. As a general precaution, non-MRI-safe contact lenses should not be worn during MRI procedures due to potential heating or displacement risks. Always confirm with your healthcare provider before using them in an MRI environment.
How should these lenses be stored, and what are the key considerations for maintaining their sterility?
Since the lenses are sterile and single-use, they should be stored in their original, sealed packaging until use. The packaging is designed to preserve sterility, so it should remain unopened until the lens is inserted. After opening, the lens must be used immediately and discarded. Avoid exposing the lens to moisture, heat, or contamination before use.