Soft Mate Hydrogen Peroxide Disinfection System
by Advanced Medical Optics, Inc.
PMA P840066
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP840066 | Date9 Aug 1988 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Full name
- Soft Mate(R) Hydrogen Peroxide Disinfection System
- Generic Name
- Accessories, soft lens products
- 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
- S013 (Normal 180 Day Track)
Overview
AI-generated summary, 20 Sep 2026
The Soft Mate Hydrogen Peroxide Disinfection System is a device classified as Accessories, Soft Lens Products, designed for the disinfection of soft contact lenses. It employs hydrogen peroxide to chemically disinfect, clean, and store soft contact lenses, ensuring microbial safety and lens integrity through an automated process. The system adheres to regulatory standards for ophthalmic accessories, specifically targeting the maintenance and hygiene of reusable soft contact lenses.
This system is intended for use in clinical and home settings, where it processes lenses via immersion in hydrogen peroxide solution. Supplied as a reusable device, it requires proper storage and maintenance to ensure functionality and sterility. Authorized under FDA_PMA (PMA Number: P840066), the system is governed by regulatory requirements outlined in 21 CFR 886.5928, with supplementary updates for manufacturer location changes. No MRI safety or single-use specifications are indicated in the regulatory data.
Other devices from Advanced Medical Optics, Inc.
Questions
AI-generated answers, 20 Sep 2026
What clinical or home settings is the Soft Mate Hydrogen Peroxide Disinfection System intended for use in?
The Soft Mate Hydrogen Peroxide Disinfection System is designed for use in both clinical environments, such as eye care offices, and home settings. It is specifically intended for the disinfection, cleaning, and storage of reusable soft contact lenses using hydrogen peroxide, ensuring microbial safety and lens integrity through an automated process.
How is the Soft Mate Hydrogen Peroxide Disinfection System supplied, and is it single-use or reusable?
The Soft Mate Hydrogen Peroxide Disinfection System is supplied as a reusable device, not a single-use product. It requires proper storage and maintenance to ensure continued functionality and sterility over time, as outlined in its regulatory documentation.
What regulatory pathway was followed for the approval of this device, and what does that mean for its use?
The Soft Mate Hydrogen Peroxide Disinfection System was authorized under an FDA Premarket Approval (PMA) with PMA Number P840066, indicating it underwent rigorous review by the FDA for safety and effectiveness. This approval confirms the device meets regulatory standards for disinfecting soft contact lenses in clinical and home settings, as governed by 21 CFR 886.5928.
Does this device require any special handling or storage conditions to maintain its effectiveness?
Since the Soft Mate Hydrogen Peroxide Disinfection System is a reusable device, its effectiveness depends on proper storage and maintenance as specified by the manufacturer. While the regulatory data does not detail specific storage conditions, typical hydrogen peroxide disinfection systems require clean, dry environments and periodic cleaning of components to prevent contamination and ensure long-term functionality.