IntelliWave3 Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A)

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

510(k) Number

K230824 ↗

FDA Product Code

LPL

Device Class

Class II

Regulation

21 CFR Part 886.5925

Advisory Committee

Ophthalmic

FDA Decision

SESE Substantially Equivalent

• Intelliwave4

  Class II

  FDA 510(k) K142641 Active Cleared 12 Jan 2015

• Intelliwave4 with HPT, Silicone Hydrogel Daily Wear Soft Contact Lens (safrofilcon A)

  Class II

  FDA 510(k) K152046 Active Cleared 24 Nov 2015

• Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D)

  Class II

  FDA 510(k) K172314 Active Cleared 20 Sep 2017

• INTELLIWAVE3

  Class II

  FDA 510(k) K100221 Active Cleared 14 Sep 2010

• Intelliwave, Soft Daily Wear Contact Lens (Acofilcon B) Hioxifilcon B) Clear and Blue Visibility Tint

  Class II

  FDA 510(k) K073621 Active Cleared 3 Jul 2008

• What is the IntelliWave3 Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A) used for?

  The IntelliWave3 Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A) is specifically designed to correct refractive errors such as myopia (nearsightedness) and hyperopia (farsightedness). Its silicone hydrogel material provides improved oxygen permeability, which enhances comfort and supports extended wear periods compared to traditional hydrogel lenses. This makes it ideal for daily use, ensuring clear vision while maintaining eye health.

• How is the IntelliWave3 lens supplied, and is it sterile?

  The IntelliWave3 Silicone Hydrogel Daily Wear Soft Contact Lens is supplied in sterile packaging, ensuring it is ready for immediate use upon opening. The sterile condition is maintained throughout its shelf life, adhering to regulatory standards for single-use medical devices. This eliminates the need for additional sterilization before use, simplifying the handling process for both clinicians and patients.

• Is the IntelliWave3 lens intended for single-use or reuse?

  The IntelliWave3 Silicone Hydrogel Daily Wear Soft Contact Lens is explicitly designed for single-use only. It is intended to be discarded after one day of wear, which reduces the risk of infection and maintains optimal eye health. This aligns with FDA guidelines for daily wear contact lenses, ensuring safety and compliance with regulatory standards.

• What regulatory approval does the IntelliWave3 lens hold, and how is it classified?

  The IntelliWave3 Silicone Hydrogel Daily Wear Soft Contact Lens has received FDA 510(k) clearance, confirming it meets regulatory requirements for safety and effectiveness. It is classified as a Class II medical device with special controls under the FDA’s regulatory framework, specifically under product code LPL for soft contact lenses intended for daily wear. This classification reflects its role in correcting refractive errors while adhering to stringent manufacturing and performance standards.

• How should the IntelliWave3 lens be stored, and what are its key specifications?

  The IntelliWave3 lens should be stored in its original, unopened sterile packaging until ready for use. Once opened, the lens must be used immediately and discarded after a single day. Key specifications include its efrofilcon A material composition, which provides enhanced oxygen permeability (critical for comfort and eye health) and its classification under 21 CFR 886.5925 for soft contact lenses. The lens is part of a broader family of variants, each identified by unique FEI numbers, ensuring compatibility with various prescription requirements.