Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact Lens

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

510(k) Number

K143190 ↗

FDA Product Code

MVN

Device Class

Class II

Regulation

21 CFR Part 886.5925

Advisory Committee

Ophthalmic

FDA Decision

SESE Substantially Equivalent

• Eye Secret 38 UV Aspheric Color(polymacon) Soft(hydrophilic) Contact Lens for Daily;Eye Secret 38 UV Aspheric Color(polymacon) 1-Day Soft(hydrophilic) Contact Lens

  Class II

  FDA 510(k) K143052 Active Cleared 16 Dec 2014

• Eye Secret 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens

  Class II

  FDA 510(k) K151586 Active Cleared 10 Aug 2015

• Eye Secret 59 UV Aspheric (Omafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear

  Class II

  FDA 510(k) K213983 Active Cleared 2 Sep 2022

• Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (Hydrophilic) Contact Lens for Daily Wear

  Class II

  FDA 510(k) K223585 Active Cleared 20 Dec 2023

• Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear, Eye Secret 55 UV Aspheric ( methafilcon A) Soft (hydrophilic) Contact lens for Daily Wear

  Class II

  FDA 510(k) K150630 Active Cleared 15 Jun 2015

• Eye Secret 38 UV Aspheric (polymacon) and Air Light 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear

  Class II

  FDA 510(k) K232839 Active Cleared 16 Dec 2024

See all devices from Yung Sheng Optical Co., Ltd. →

• What is the primary use case for the Eye Secret 38 UV Aspheric contact lens, and who is it designed for?

  The Eye Secret 38 UV Aspheric contact lens is designed for the correction of myopia (nearsightedness) in individuals with healthy eyes, including both aphakic (without a natural lens) and non-aphakic (with a natural lens) patients. It is a daily-wear, single-use soft hydrophilic lens made of polymacon material, ensuring comfort and clarity for one-day use.

• Is this contact lens reusable, or is it intended for single-use only?

  This lens is explicitly intended for single-use only, meaning it is designed to be worn for one day and then discarded. The packaging and labeling reflect this as a disposable device, ensuring hygiene and safety for each wearer.

• What materials and features does the Eye Secret 38 UV Aspheric lens include, and how does that benefit the wearer?

  The lens is made of polymacon, a hydrophilic material that provides moisture retention for comfort, and includes UV protection to shield the eyes from harmful ultraviolet rays. The aspheric design ensures optimal vision correction by reducing spherical aberrations, which can improve clarity and reduce eye strain.

• How is this lens regulated, and what does that mean for clinicians or buyers?

  The Eye Secret 38 UV Aspheric lens is classified as a Class II medical device under FDA regulations (product code MVN, regulation number 886.5925) and was cleared via a 510(k) submission (K143190). This means it has undergone FDA review to demonstrate substantial equivalence to a predicate device, ensuring it meets safety and effectiveness standards for ophthalmic use. Clinicians and buyers can rely on this regulatory pathway as evidence of its compliance with U.S. medical device regulations.

• Are there multiple sizes or models available for this lens, and how would a clinician determine the correct fit?

  While the provided data does not specify exact dioptric powers or base curve measurements, the OpenFDA registration numbers indicate multiple lot or batch identifiers, suggesting this lens may come in various prescriptions (e.g., different powers for myopia correction). Clinicians should rely on standard eye exams to determine the appropriate prescription, including base curve and diameter, ensuring a proper fit for each patient’s corneal shape and refractive error.