CooperVision Peroxide System
PMA P830023
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP830023 | Date3 Jun 1986 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Generic name
- Accessories, soft lens products
- FDA applicant
- Alcon Laboratories
- PMA number
- FDA product code
- LPN
- Device class
- Class II
- Regulation
- 21 CFR Part 886.5928
- Advisory committee
- Ophthalmic
- FDA decision
- APPR Approved
- PMA supplement
- S001
Overview
AI-generated summary, 18 Sep 2026
The CooperVision Peroxide System is a device classified as Accessories, Soft Lens Products, designed for the disinfection and storage of soft contact lenses. It employs a hydrogen peroxide-based solution to effectively clean, disinfect, and maintain lens hygiene, reducing the risk of microbial contamination and protein buildup on the lenses.
This system is intended for use in ophthalmic settings and is supplied as a reusable device with disposable components. It requires FDA_PMA authorization (PMA Number: P830023) and is regulated under the classification of Class II medical devices (Regulation Number: 886.5928). The system operates using a peroxide solution and includes components for lens storage and processing, adhering to strict regulatory standards for ophthalmic accessories.
Other devices from Alcon Laboratories, Inc.
Questions
AI-generated answers, 18 Sep 2026
What is the primary purpose of the CooperVision Peroxide System and how does it differ from other contact lens cleaning methods?
The CooperVision Peroxide System is designed specifically for the disinfection and storage of soft contact lenses using a hydrogen peroxide-based solution. Unlike traditional saline or multipurpose solutions, it actively cleans, disinfects, and reduces microbial contamination and protein buildup on lenses, which helps maintain lens hygiene and extends their lifespan. This system is tailored for ophthalmic use and is regulated as a Class II medical device under FDA_PMA authorization.
Is the CooperVision Peroxide System reusable, and if so, what components are disposable?
Yes, the CooperVision Peroxide System is a reusable device, but it includes disposable components that must be replaced periodically. The system itself is designed for long-term use, while specific parts like the peroxide solution containers or lens storage cases may be intended for single-use or replacement to ensure hygiene and effectiveness.
What regulatory pathway does the CooperVision Peroxide System follow, and what does this mean for its use in clinical settings?
The CooperVision Peroxide System follows the FDA_PMA (Premarket Approval) pathway, which is required for Class II medical devices. This means the device has undergone rigorous review by the FDA to ensure its safety and effectiveness for its intended use—disinfection and storage of soft contact lenses in ophthalmic settings. Clinicians can rely on this approval to confirm the system meets regulatory standards for use in professional environments.
How is the CooperVision Peroxide System supplied, and what should clinicians consider when ordering or stocking it?
The system is supplied as a reusable device with disposable components, likely including peroxide solution containers and lens storage cases. Clinicians should consider ordering the base unit along with replacement disposable parts to ensure continuous, sterile operation. Since it’s regulated under the product code LPN (Lens Processing and Storage), stocking should account for both the reusable components and the necessary consumables for proper lens care.
What does the advisory committee classification (Ophthalmic, OP) indicate about the intended use of this device?
The advisory committee classification (Ophthalmic, OP) indicates that this device was reviewed by the FDA’s Ophthalmic Devices Panel, confirming its primary use in ophthalmic applications. This classification ensures the system is specifically designed and validated for contact lens care in eye care settings, rather than general medical or non-clinical use. It reflects the device’s focus on maintaining lens hygiene for patients.