Burton Slit Lamp
by R.H. Burton Co. 510(k)
Active
510(k) K924787
Overview
A biomicroscope, slit-lamp, AC-powered device used in ophthalmic examinations. It is a slit lamp biomicroscope designed for detailed visualization of anterior eye structures.
The device is supplied as a reusable instrument requiring appropriate cleaning and maintenance between uses. It operates on AC power and is classified as a Class II medical device under FDA regulation 886.1850 with product code HJO, having received traditional 510(k) clearance as substantially equivalent to a predicate device.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK924787 | Date27 Jan 1993 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- 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
- HJO
- Device Class
- Class II
- Regulation
- 21 CFR Part 886.1850
- Advisory Committee
- Ophthalmic
- FDA Decision
- SESE Substantially Equivalent
Other devices from R.H. Burton Co.
Questions
What is the Burton Slit Lamp used for?
The Burton Slit Lamp is a biomicroscope used in ophthalmic examinations to provide detailed visualization of anterior eye structures, enabling clinicians to assess corneal, iris, lens, and other front-of-eye conditions with high-resolution illumination and magnification.
Is the Burton Slit Lamp reusable or single-use?
The Burton Slit Lamp is supplied as a reusable instrument, meaning it is designed for multiple uses over its lifetime, provided it undergoes appropriate cleaning and maintenance between each patient use to ensure safety and functionality.
What power source does the Burton Slit Lamp require?
The Burton Slit Lamp operates on AC power, meaning it must be connected to a standard alternating current electrical outlet to function, and does not rely on batteries or internal power sources for operation.
How is the Burton Slit Lamp maintained between uses?
The Burton Slit Lamp requires appropriate cleaning and maintenance between uses, as specified by the manufacturer’s instructions, to prevent cross-contamination and ensure optimal optical and mechanical performance during subsequent ophthalmic examinations.
What regulatory pathway was used for the Burton Slit Lamp?
The Burton Slit Lamp received traditional 510(k) clearance from the FDA, demonstrating it is substantially equivalent to a legally marketed predicate device, which allowed it to be cleared for commercial distribution under FDA regulation 886.1850 with product code HJO.