SOF PRO-Clean Contact Lens Cleaner

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

Generic Name

Accessories, soft lens products

PMA Number

P810041 ↗

FDA Product Code

LPN

Device Class

Class II

Regulation

21 CFR Part 886.5928

Advisory Committee

Ophthalmic

FDA Decision

APPR Approved

PMA Supplement

S004

• Lobob Universal Contact Lens Cleaner

  Class II

  FDA 510(k) K990044 Active Cleared 11 Feb 1999

• Optimum Wetting and Rewetting Drop

  Class II

  FDA 510(k) K001428 Active Cleared 26 May 2000

• Optimum Cleaning, Disinfecting and Storage Solution

  Class II

  FDA 510(k) K001964 Active Cleared 18 Jul 2000

• Modification to Optimum Cleaning, Disinfecting and

  Class II

  FDA 510(k) K014162 Active Cleared 15 Jan 2002

• What is the SOF PRO-Clean Contact Lens Cleaner specifically designed to remove from contact lenses and how does this benefit the user?

  The SOF PRO-Clean Contact Lens Cleaner is formulated to remove dirt, protein deposits, and oils from soft contact lens surfaces. This helps maintain lens hygiene, prolongs lens longevity, and reduces the risk of irritation or infection by ensuring lenses remain clean between uses.

• How is the SOF PRO-Clean Contact Lens Cleaner supplied, and is it intended for single-use or reusable applications?

  The solution is supplied in a 2-ounce sterile formulation, packaged for single-use per lens. This ensures each lens receives a fresh, uncontaminated cleaning solution, minimizing the risk of cross-contamination or residue buildup.

• What regulatory pathway does the SOF PRO-Clean Contact Lens Cleaner follow, and what class does it belong to?

  The SOF PRO-Clean Contact Lens Cleaner is regulated under the FDA’s Premarket Approval (PMA) pathway with PMA number P810041 and falls under device class II (product code LPN). This classification reflects its role as an accessory for ophthalmic use, subject to stricter oversight due to its direct contact with the eye.

• Is this product intended for use in clinical or home settings, and what special considerations should be taken during storage?

  While the SOF PRO-Clean Contact Lens Cleaner is designed for ophthalmic use, it can be used in both clinical and home settings for cleaning soft contact lenses. Since it is sterile upon packaging, it should be stored in a cool, dry place away from direct sunlight to preserve sterility and efficacy until use.