GEO Magic Color (Polymacon) Soft (Hydrophilic) Contact Lens

No FDA recalls found in the data synced 22 Oct 2026.

Trade Name

Magic Color

Model / Reference

IMAGE COLOR, 1-DAY EYENIQ, SI-HYDROGEL UV, many

Primary DI / UDI-DI

880032625ICRM001BB

Basic UDI-DI

880032625GSU4

510(k) Number

K110835 ↗

FDA Product Code

LPL

EMDN Code

Q0210040102 Contact lenses - hydrogel, reusable

Device Class

Class IIa EUDAMED

Class II 510(k)

Regulation

21 CFR Part 886.5925

Special Device Type

Standard soft contact lenses

Advisory Committee

Ophthalmic

FDA Decision

SESE Substantially Equivalent

• HOLLYWOOD PLATINUM FL-D34 Jade Green

  Class II

  GUDID on market

• MAGIC COLOR FL-D45 Satin Gray

  Class II

  GUDID on market

• MAGIC COLOR FL-D44 Jade Green

  Class II

  GUDID on market

• HOLLYWOOD PLATINUM FL-D35 Satin Gray

  Class II

  GUDID on market

• HOLLYWOOD PLATINUM FL-D31 Sweet Violet

  Class II

  GUDID on market

• MAGIC COLOR FL-D41 Sweet Violet

  Class II

  GUDID on market

See all devices from GEO Medical Co., Ltd. →

• Are these contact lenses designed for daily wear only, or can they be worn overnight as well?

  These lenses are explicitly labeled as Daily Wear only, meaning they are intended for continuous wear during waking hours and should not be worn overnight. The design prioritizes comfort and clarity for extended daytime use, but overnight wear is not supported or approved for this product.

• How do I prepare the GEO MAGIC COLOR (POLYMACON) contact lenses for use, given they are non-sterile?

  The lenses are supplied in a non-sterile state and must be sterilized by the user prior to first use. The manufacturer recommends following a disinfection process (specific protocol not detailed in the data) to ensure safety. Always adhere to proper cleaning and sterilization guidelines to maintain hygiene and prevent infection.

• Are these lenses available in multiple sizes and prescriptions, and how do I determine the correct fit?

  Yes, these lenses come in various sizes and powers, as indicated by the multiple FEI codes listed in the data. The correct fit depends on the user’s prescription and corneal curvature, so they must be professionally fitted by an eye care provider. Never self-select a lens without expert guidance to avoid discomfort or vision issues.

• Can these lenses be reused, or are they intended for single-use only?

  The device is supplied as both single-use and multi-use, depending on the specific FEI code assigned to the batch (e.g., some codes indicate single-use, while others allow for multi-use). Always check the packaging or consult the manufacturer’s instructions to confirm the reuse eligibility for your specific lenses, as improper reuse can compromise safety and clarity.

• What regulatory pathways have been followed for this product, and how does that affect its use?

  This device has undergone FDA 510(k) clearance and complies with EU MDR (Medical Device Regulation). The FDA classified it under product code LPL (Lenses, Soft Contact, Daily Wear), and it was deemed substantially equivalent to a predicate device. These pathways ensure the product meets safety and performance standards, but compliance with local regulations (e.g., sterilization, handling, and disposal) remains the responsibility of the user or facility.