AOI LC-40 Phacoemulsifier
by American Optisurgical, Inc.
510(k) K952331
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK952331 | Date16 Aug 1995 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
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, 1 Oct 2026
The AOI LC-40 Phacoemulsifier is a Unit, Phacofragmentation device designed for ophthalmic surgery. It employs ultrasonic energy to emulsify and aspirate cataracts, facilitating their removal from the eye through a small incision. This process, known as phacoemulsification, is a standard technique for treating cataracts by replacing the clouded natural lens with an intraocular lens implant.
This device is intended for use in sterile operating room environments and is classified as a Class II medical device under FDA regulations. Supplied as a reusable instrument, it requires proper cleaning, sterilization, and maintenance per manufacturer guidelines. The AOI LC-40 Phacoemulsifier holds an FDA 510(k) clearance (K952331) and is regulated under 21 CFR 886.4670. No MRI safety information is specified, and its use must adhere to established ophthalmic surgical protocols.
Other devices from American Optisurgical, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the AOI LC-40 Phacoemulsifier used for?
The AOI LC-40 Phacoemulsifier is designed specifically for phacoemulsification, a surgical technique used to treat cataracts. It employs ultrasonic energy to emulsify and aspirate the clouded natural lens through a small incision, allowing for its removal and replacement with an intraocular lens implant. This minimally invasive procedure is the standard approach for cataract surgery.
Is the AOI LC-40 Phacoemulsifier reusable or single-use?
The AOI LC-40 Phacoemulsifier is a reusable instrument. Like all reusable medical devices used in sterile operating room environments, it requires thorough cleaning, sterilization, and regular maintenance following the manufacturer’s guidelines to ensure safety and performance for repeated use.
What maintenance or sterilization procedures are required for the AOI LC-40?
Since the AOI LC-40 is a reusable device, it must be cleaned and sterilized between uses to prevent contamination and maintain functionality. The manufacturer provides specific instructions for cleaning, sterilization, and maintenance, which must be strictly followed to comply with surgical protocols and regulatory standards. Improper handling can compromise device integrity and patient safety.
Does the AOI LC-40 Phacoemulsifier have any MRI safety information?
The AOI LC-40 Phacoemulsifier does not specify MRI safety information in its documentation. If MRI imaging is required for a patient post-surgery or during follow-up, clinicians must ensure the device’s components are not present in the body or within the MRI scan area to avoid interference or safety risks.
What regulatory approval does the AOI LC-40 Phacoemulsifier hold?
The AOI LC-40 Phacoemulsifier holds an FDA 510(k) clearance (K952331), indicating it has been deemed substantially equivalent to a legally marketed device. It is classified as a Class II medical device under FDA regulations and is regulated under 21 CFR 886.4670. This clearance allows it to be legally marketed and used in the United States for its intended purpose.