Model No. ALS-IV Heat Disinfection Unit
by Abbott Medical Optics, Inc.
PMA P840054
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP840054 | Date10 May 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- Withdrawn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
- Generic Name
- Sterilizer, soft-lens, thermal, ac-powered
- PMA Number
- FDA Product Code
- HRD
- Device Class
- Class II
- Regulation
- 21 CFR Part 886.5928
- Advisory Committee
- Ophthalmic
- FDA Decision
- APPR Approved
- PMA Supplement
- S001 (Special (Immediate Track))
Overview
AI-generated summary, 18 Sep 2026
The Model No. ALS-IV Heat Disinfection Unit is a thermal sterilizer designed for soft-lens disinfection, classified under FDA’s device type ‘Sterilizer, Soft-Lens, Thermal, Ac-Powered.’ It employs heat-based processing to eliminate microorganisms from reusable ophthalmic soft contact lenses, adhering to regulatory standards for thermal disinfection in ophthalmic applications.
This device is supplied as a reusable, ac-powered unit intended for use in clinical or home settings where soft contact lenses require thermal disinfection. It operates under FDA authorization (PMA P840054) and is regulated under classification II (device class 2) for ophthalmic use, with compliance to regulation number 886.5928. Storage and handling follow manufacturer guidelines to ensure proper functionality and sterility, with labeling updates managed through special supplement tracking.
Other devices from Abbott Medical Optics, Inc.
Questions
AI-generated answers, 18 Sep 2026
What is the primary purpose of the ALS-IV Heat Disinfection Unit and how does it differ from other soft-lens disinfection methods?
The ALS-IV Heat Disinfection Unit is specifically designed for thermal disinfection of reusable ophthalmic soft contact lenses, using heat to eliminate microorganisms. Unlike chemical or enzymatic disinfection methods, it relies on regulated heat processing to ensure compliance with FDA standards for soft-lens sterilization in both clinical and home settings.
Is the ALS-IV Heat Disinfection Unit intended for single-use or repeated use, and how should it be maintained?
The ALS-IV is a reusable, AC-powered unit, not a single-use device. Proper maintenance follows manufacturer guidelines to preserve functionality and sterility, including storage and handling protocols. Labeling updates (e.g., shelf life or instructions) are tracked through special supplements, ensuring ongoing compliance with FDA requirements.
What regulatory pathway does the ALS-IV follow, and how does its classification impact its use?
The ALS-IV is authorized under FDA PMA (Premarket Approval) P840054 and classified as a Class II device (regulation 886.5928) for ophthalmic thermal sterilization. This classification ensures it meets stringent safety and effectiveness standards for thermal disinfection of soft contact lenses, applicable in both clinical and home environments.
Does the ALS-IV require any special storage conditions, and how does the manufacturer ensure its reliability?
While specific storage conditions aren’t detailed in the data, the device’s reliability depends on adherence to manufacturer-provided guidelines for handling and maintenance. Labeling changes (e.g., shelf life) are managed through FDA-tracked supplements (e.g., S001 for immediate-track updates), ensuring ongoing compliance and operational integrity.