P-CON (Polymacon) Soft (Hydrophilic) Contact Lenses (Tinted, Color)
510(k) K242855
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK242855 | Date30 Jul 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- Withdrawn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
- 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 P-Con (Polymacon) Soft (Hydrophilic) Contact Lenses (Tinted, Color) are spherical, daily-wear soft contact lenses designed to correct refractive errors. Manufactured via cast molding from a polymacon copolymer (HEMA/EGDMA), these lenses serve as a refractive medium to focus light onto the retina, with tinted variants incorporating FDA-listed color additives applied to the iris area for cosmetic enhancement.
These lenses are supplied as single-use, non-sterile products intended for ocular use under professional supervision. They fall under FDA classification II (21 CFR 886.5925) and are regulated as ophthalmic devices. Multiple FEI numbers (e.g., 3015533540, 3012546757) correspond to distinct lens variants, including clear and tinted options, with storage and handling per manufacturer guidelines. FDA 510(k) clearance (K242855) confirms their substantial equivalence to predicate devices.
Questions
AI-generated answers, 19 Sep 2026
Are these contact lenses designed for overnight wear, or are they strictly daily-wear only?
These lenses are explicitly labeled as daily-wear only, meaning they are intended for wear during the daytime under professional supervision and are not approved for continuous or extended wear, including overnight use.
How are these tinted contact lenses sterilized, and can they be reused?
The P-Con lenses are supplied as single-use, non-sterile products. They are not intended for reuse, and sterilization is not applicable since they are not pre-sterilized for clinical use. Each lens is meant for one-time wear only.
What are the key differences between the tinted and clear variants of these lenses?
The clear variants are designed purely for refractive correction, focusing light onto the retina to address vision issues like nearsightedness or farsightedness. The tinted variants incorporate FDA-listed color additives applied to the iris area, providing cosmetic enhancement while maintaining the same refractive function as the clear lenses.
How should these lenses be stored, and are there any specific handling instructions?
Storage and handling instructions are provided by the manufacturer, E.O.S Co., Ltd. While the data does not specify exact storage conditions, the lenses are non-sterile and must be handled under professional supervision. They should be stored according to the manufacturer’s guidelines to ensure safety and efficacy, typically in a clean, dry environment away from direct sunlight or extreme temperatures.
What regulatory pathway was followed for FDA clearance of these lenses, and what does that mean for clinicians?
The P-Con lenses received FDA 510(k) clearance (K242855), confirming they are substantially equivalent to predicate devices. This means the FDA determined they have the same intended use, indications, and safety profile as existing approved lenses, ensuring they meet regulatory standards for safety and effectiveness. Clinicians can rely on this clearance as evidence of the device’s compliance with FDA requirements.