Drolite Light Source
by Vision Medical, Inc. 510(k)
Active
510(k) K913273
Overview
The Drolite Light Source is an AC-powered transilluminator, classified as a Class II medical device under FDA regulation 886.1945. It is designed to transmit light through tissues, facilitating ophthalmic examinations by illuminating internal structures for visual assessment.
This device is supplied as a reusable instrument and is intended for use in ophthalmic settings. It is regulated under the FDA’s 510(k) clearance (K913273) and falls under the HJM product code. No sterility or single-use specifications are indicated in the data, and its MRI safety is not addressed. Storage and handling instructions are not provided in the regulatory records.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK913273 | Date4 Dec 1991 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- Full name
- Drolite(Tm) Light Source
- 510(k) Number
- FDA Product Code
- HJM
- Device Class
- Class II
- Regulation
- 21 CFR Part 886.1945
- Advisory Committee
- Ophthalmic
- FDA Decision
- SESE Substantially Equivalent
Other devices from Vision Medical, Inc.
Questions
Is the Drolite Light Source intended for single-use or can it be reused in clinical settings?
The Drolite Light Source is explicitly described as a reusable instrument in the regulatory records. Since no sterility or single-use specifications are mentioned, it is designed for repeated use in ophthalmic examinations, provided proper cleaning and maintenance protocols are followed.
What types of ophthalmic examinations is the Drolite Light Source primarily used for?
The device is designed to transmit light through tissues, making it suitable for illuminating internal ocular structures during ophthalmic examinations. While the exact clinical applications aren’t detailed, its classification as an AC-powered transilluminator and its regulatory listing under the ophthalmic specialty suggest it aids in procedures like retinal or corneal assessments where internal visualization is critical.
How is the Drolite Light Source powered, and what does this mean for its use in clinical settings?
The Drolite Light Source is AC-powered, meaning it requires a standard electrical outlet for operation. This design ensures consistent illumination during use, which is essential for prolonged or detailed ophthalmic examinations. Clinicians should ensure the device is plugged into a reliable power source and that any associated cables or connections are securely maintained to avoid interruptions.
Are there specific storage instructions provided for the Drolite Light Source?
The regulatory records do not include explicit storage or handling instructions for the Drolite Light Source. Since it is reusable, users should follow general best practices for medical devices—such as keeping it in a clean, dry environment away from direct sunlight or extreme temperatures—to preserve its functionality and ensure longevity.
What regulatory pathway was followed for the FDA clearance of the Drolite Light Source, and what does this imply for its use?
The Drolite Light Source received FDA 510(k) clearance (K913273) under the Traditional 510(k) pathway, with a decision of Substantially Equivalent (SESE) to a predicate device. This means the FDA determined it has the same intended use and technological characteristics as a previously cleared transilluminator, ensuring it meets safety and effectiveness standards for ophthalmic use as outlined in 21 CFR 886.1945. Clinicians can rely on this clearance as evidence of regulatory compliance for its intended applications.