Envision G31 P.E. Pak
by Envision, Inc. 510(k)
Active
510(k) K832424
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK832424 | Date12 Sep 1983 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- HQC
- Device Class
- Class II
- Regulation
- 21 CFR Part 886.4670
- Advisory Committee
- Ophthalmic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Envision G31 Phacoemulsification Pak is a phacofragmentation unit designed for ophthalmic surgical procedures. It is classified as a Class II medical device and is intended for use in cataract surgery to emulsify and remove the lens through a small incision, facilitating lens replacement with an intraocular lens (IOL).
This device is supplied as a reusable system and is intended for use in sterile operating room environments. It is regulated under FDA 510(k) clearance (K832424) and falls under the Ophthalmic advisory committee category. The device is not MRI-safe, and its use requires adherence to standard surgical protocols. Storage and handling follow manufacturer guidelines to maintain sterility and functionality.
Other devices from Envision, Inc.
Questions
AI-generated answers, 19 Sep 2026
What is the primary use of the Envision G31 P.E. Pak in cataract surgery, and how does it function during the procedure?
The Envision G31 P.E. Pak is a phacofragmentation unit specifically designed for cataract surgery. It emulsifies and removes the clouded lens (cataract) through a small incision, making it easier to replace with an intraocular lens (IOL). This process helps minimize the size of the surgical incision while effectively breaking down the lens for safe removal.
Is the Envision G31 P.E. Pak intended for single-use or reusable applications, and what does this mean for maintenance?
The Envision G31 P.E. Pak is supplied as a reusable system, meaning it is meant to be used multiple times after proper cleaning, sterilization, and maintenance. Since it operates in sterile surgical environments, adherence to manufacturer guidelines for storage, handling, and reprocessing is critical to ensure sterility and functionality between uses.
Are there any special storage or handling requirements for the Envision G31 P.E. Pak to maintain its performance?
Yes, the Envision G31 P.E. Pak must be stored and handled according to the manufacturer’s guidelines to preserve sterility and operational integrity. Since it is a reusable device, proper cleaning, sterilization, and storage protocols must be followed to prevent contamination and ensure reliable performance during cataract surgery.
Does the Envision G31 P.E. Pak have any limitations regarding compatibility with medical imaging equipment, such as MRI?
The Envision G31 P.E. Pak is not MRI-safe, meaning it should not be used or stored in environments where MRI imaging is performed. This is an important consideration for surgical planning and equipment placement in facilities where MRI scans are conducted.
How is the regulatory status of the Envision G31 P.E. Pak determined, and what does this mean for clinicians or facilities considering its use?
The Envision G31 P.E. Pak holds FDA 510(k) clearance (K832424) and is classified as a Class II medical device, indicating it has undergone regulatory review to demonstrate substantial equivalence to a predicate device. Clinicians or facilities should confirm compliance with FDA guidelines and manufacturer instructions to ensure safe and effective use in cataract surgery procedures.