EOL Model LIO
by Eol, Inc. 510(k)
Active
510(k) K881984
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK881984 | Date6 Sep 1988 | 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- Withdrawn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
- HLI
- Device Class
- Class II
- Regulation
- 21 CFR Part 886.1570
- Advisory Committee
- Ophthalmic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The EOL Model LIO is an Ac-Powered Ophthalmoscope, a diagnostic device designed for examining the interior structures of the eye. It provides illumination and magnification to assess retinal conditions, optic disc health, and other intraocular features, aiding in the diagnosis and monitoring of ophthalmic disorders.
This device is intended for use in clinical ophthalmology settings and is supplied as a reusable, non-sterile instrument. It operates on alternating current (AC) power and is classified as a Class II medical device under FDA regulations. The Model LIO was cleared via a Traditional 510(k) pathway, with its regulatory submission filed under K881984 and product code HLI. Storage and maintenance should follow manufacturer guidelines to ensure proper functionality and longevity.
Questions
AI-generated answers, 19 Sep 2026
What clinical settings is the EOL Model LIO ophthalmoscope designed for, and how does it assist in patient care?
The EOL Model LIO is specifically designed for use in clinical ophthalmology settings, such as eye clinics, hospitals, and private practice offices. It provides illumination and magnification to examine the interior structures of the eye, including the retina, optic disc, and other intraocular features. This aids clinicians in diagnosing and monitoring ophthalmic disorders by enabling detailed visualization of retinal conditions, helping to detect abnormalities like glaucoma, diabetic retinopathy, or macular degeneration.
Is the EOL Model LIO a single-use or reusable device, and what does that mean for maintenance and cleaning?
The EOL Model LIO is a reusable, non-sterile instrument. Since it is not single-use, it requires proper cleaning and maintenance between patient examinations to ensure hygiene and functionality. The manufacturer provides guidelines for storage and upkeep, which should be followed to maintain the device’s performance and longevity over time.
How is the EOL Model LIO powered, and does this affect its portability or usability in different settings?
The EOL Model LIO is an AC-powered ophthalmoscope, meaning it requires access to an electrical outlet for operation. This design makes it less portable than battery-powered alternatives, as it cannot be used in locations without a power source. However, its reliance on AC power ensures consistent performance in clinical settings where outlets are readily available.
What regulatory pathway was used for the FDA clearance of the EOL Model LIO, and what does that mean for its safety and equivalence?
The EOL Model LIO was cleared through the Traditional 510(k) pathway, with a decision of *Substantially Equivalent* (SESE) to a predicate device. This means the FDA determined that the device has the same intended use and technological characteristics as a previously cleared ophthalmoscope, ensuring it meets established safety and effectiveness standards. The clearance was filed under K881984 and classified as a Class II medical device.
Are there multiple models or variations of the EOL Model LIO, and how can I verify compatibility with my practice’s needs?
The provided data lists multiple registration numbers (e.g., 3009685433, 1000391004) associated with the EOL Model LIO, which may indicate variations or updates in manufacturing or distribution. However, the core specifications (AC-powered, reusable, non-sterile) remain consistent. To confirm compatibility, verify the exact model or variant in use with the manufacturer, Eol, Inc., or consult the device’s technical documentation to ensure alignment with your practice’s requirements.