Hydrogen Peroxide Disinfection Solution

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

Generic Name

Accessories, soft lens products

PMA Number

P850026 ↗

FDA Product Code

LPN

Device Class

Class II

Regulation

21 CFR Part 886.5928

Advisory Committee

Ophthalmic

FDA Decision

APPR Approved

PMA Supplement

S002 (THIRTY DAY TRACK)

• Bandage

  Class I

  FDA 510(k) K761093 Active Cleared 6 Jan 1977

• Charter Wetting Solution for Hard Contact Lenses

  Unclassified

  FDA 510(k) K862952 Active Cleared 25 Sep 1986

• Sterile Saline Solution

  Class I

  FDA 510(k) K843797 Active Cleared 18 Jan 1985

• Charter Laboratories Inc. Lens Lubricant

  Unclassified

  FDA 510(k) K863974 Active Cleared 10 Nov 1986

• Sterile Water

  Not classified

  FDA 510(k) K843796 Active Cleared 10 Dec 1984

• Charter Hard Contact Lens Cleaning Solution

  Unclassified

  FDA 510(k) K865111 Active Cleared 20 Jan 1987

See all devices from Paco Pharmaceutical Services, Inc. →

• What is the primary purpose of this Hydrogen Peroxide Disinfection Solution in ophthalmic care, and how does it differ from other lens cleaning solutions?

  This solution is specifically designed as an accessory for soft contact lenses, using chemical action to disinfect and clean lenses while reducing microbial contamination. Unlike some other solutions, it relies on hydrogen peroxide to break down organic matter and kill microbes, which helps maintain the integrity of soft lenses during the process. It is intended for single-use applications in ophthalmic settings, ensuring sterility and efficacy per FDA guidelines.

• Is this solution reusable, or is it meant for single-use only? How should it be handled to maintain sterility?

  The solution is intended for single-use applications in ophthalmic settings, meaning each unit is designed for one-time use to ensure sterility and prevent contamination. Proper storage and handling—following the manufacturer’s guidelines—are critical to preserve its efficacy and sterility before use. Reuse is not recommended, as it could compromise microbial safety.

• What regulatory pathway does this device follow, and what does that mean for clinicians or facilities using it?

  This device follows the FDA Pre-Market Approval (PMA) pathway, as indicated by the PMA number P850026. This means it has undergone rigorous review by the FDA to ensure safety and effectiveness for its intended use as an accessory for soft lens products. Clinicians or facilities using it can rely on this approval to confirm its compliance with FDA regulations under product code LPN and regulation number 886.5928.

• Are there different sizes or models of this solution, or is it supplied in a standardized format?

  The provided data does not specify distinct sizes or models beyond its classification as a sterile liquid solution for single-use in ophthalmic disinfection. It is supplied as a standardized product under the trade name *Hydrogen Peroxide Disinfection Solution*, with no variations mentioned in the regulatory records. Facilities should confirm the exact packaging details directly with the manufacturer.