IDEL 67 Contact Lens

No FDA recalls found in the data synced 6 Oct 2026.

Generic Name

Lenses, soft contact, daily wear

PMA Number

P860009 ↗

FDA Product Code

LPL

Device Class

Class II

Regulation

21 CFR Part 886.5925

Advisory Committee

Ophthalmic

FDA Decision

APPR Approved

PMA Supplement

S001 (Normal 180 Day Track)

• Contaflex 55 (Methafilcon) Spherical Soft Contact Lens for Daily Wear (Clear and Tinted, Lathe-Cut)

  Class II

  FDA 510(k) K023989 Active Cleared 26 Feb 2003

• OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100 (hexafocon A) Daily Wear Contact Lens

  Class II

  FDA 510(k) K180616 Active Cleared 25 Apr 2018

• Contaflex 38 (Polymacon) Spherical Soft Contact Lens for Daily Wear (Clear and Tinted, Lathe-Cut)

  Class II

  FDA 510(k) K023987 Active Cleared 26 Feb 2003

• CONTAFLEX 54 (hioxifilcon D) Spherical Soft Contact Lens for Daily Wear, CONTAFLEX 49 (hioxifilcon B) Spherical Soft Contact Lens for Daily Wear,

  Class II

  FDA 510(k) K150590 Active Cleared 10 Jul 2015

• Hyper GP (tisilfocon A) Daily Wear Contact Lens

  Class II

  FDA 510(k) K182304 Active Cleared 23 Nov 2018

• OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E)

  Class II

  FDA 510(k) K160859 Active Cleared 13 Jul 2016

See all devices from Contamac, Ltd. →

• What is the IDEL 67 Contact Lens primarily used for and how does it differ from other daily wear contact lenses?

  The IDEL 67 Contact Lens is designed for corneal or scleral placement to correct refractive errors or improve vision, specifically as a soft hydrogel lens intended for daily wear. Unlike some other daily wear lenses, it is explicitly manufactured for single-use or disposable application, ensuring hygiene and comfort for extended daily use while maintaining clarity and visual acuity. The hydrogel material also provides oxygen permeability, which supports eye health during prolonged wear.

• How is the IDEL 67 Contact Lens supplied, and what should I consider when storing it?

  The IDEL 67 Contact Lens is supplied sterile and packaged individually, making it suitable for both clinical and home use. To preserve sterility and integrity, storage must follow the manufacturer’s guidelines, though no MRI compatibility restrictions are noted. Always check the packaging for expiration dates and handle it with clean, dry hands to avoid contamination.

• Is the IDEL 67 Contact Lens reusable, or is it intended for single-use only?

  The IDEL 67 Contact Lens is explicitly designed for single-use or disposable application, as stated in its description. This design ensures hygiene and reduces the risk of infection or irritation associated with reusable lenses, making it ideal for daily wear without the need for cleaning or disinfection.

• What regulatory pathway does the IDEL 67 Contact Lens follow, and what does this mean for its use?

  The IDEL 67 Contact Lens is authorized under the FDA’s Premarket Approval (PMA) process, specifically under PMA number P860009. This means it has undergone rigorous review to ensure safety and effectiveness for its intended use as a soft contact lens for daily wear. The approval also falls under the LPL (Lenses, Soft Contact) product code, adhering to FDA standards for ophthalmic devices. Clinicians and users can rely on this regulatory clearance for confidence in its performance.