Keeler Dual Lightsource

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K861746 ↗

FDA Product Code

HPQ

Device Class

Class II

Regulation

21 CFR Part 886.4335

Advisory Committee

Ophthalmic

FDA Decision

SESE Substantially Equivalent

• Henson Cfa 3000 Central Visual Field Screener

  Class I

  FDA 510(k) K891610 Active Cleared 5 Jun 1989

• Keeler Tearscope-Plus

  Class II

  FDA 510(k) K973064 Active Cleared 7 Apr 1998

• Panoramic Loupes - Various

  Class II

  FDA 510(k) K841293 Active Cleared 9 May 1984

• Vickers Ergomatic Micros Instr-Long R or L Handed

  Class I

  FDA 510(k) K853180 Active Cleared 28 Oct 1985

• Henson - Hamblin Cfs 2000 Central Field Screen

  Class I

  FDA 510(k) K864467 Active Cleared 15 Dec 1986

• Spectacle Indirect Ophthalmoscope

  Class II

  FDA 510(k) K841292 Active Cleared 9 May 1984

See all devices from Keeler Instruments, Inc. →

• What types of eye procedures can the Keeler Dual Lightsource be used for, and why is dual illumination beneficial during these procedures?

  The Keeler Dual Lightsource is designed for ophthalmic use, providing enhanced visibility during both surgical and diagnostic procedures involving ocular structures. Dual illumination is particularly beneficial because it allows clinicians to adjust lighting angles independently, reducing shadows and improving contrast on the eye’s surface. This is especially useful for intricate tasks like cataract surgery, retinal examinations, or procedures requiring precise visualization of delicate tissues.

• Is the Keeler Dual Lightsource meant for single-use or reusable applications, and how should it be maintained?

  The Keeler Dual Lightsource is a reusable ophthalmic instrument, intended for repeated use in clinical settings where stable, adjustable lighting is required. Since it is not single-use, proper maintenance—including cleaning, calibration, and adherence to standard ophthalmic equipment protocols—is essential to ensure consistent performance and safety. The manufacturer’s guidelines should be followed for storage and handling to prevent contamination or damage.

• What power source does the Keeler Dual Lightsource use, and does this affect its portability or setup requirements?

  The Keeler Dual Lightsource operates on alternating current (AC) power, meaning it requires a standard electrical outlet for use. This design makes it less portable compared to battery-powered alternatives but ensures reliable, consistent illumination without battery replacement concerns. Clinicians should ensure the device is plugged into a stable power source and that the workspace has appropriate electrical access.

• How is the regulatory status of the Keeler Dual Lightsource determined, and what does the FDA classification mean for its use?

  The Keeler Dual Lightsource holds FDA 510(k) clearance (K861746) under the Traditional review pathway, classified as a Device Class II product (Product Code HPQ) for operating, AC-powered headlamps in ophthalmic use. This classification means it has been deemed substantially equivalent to a legally marketed predicate device and meets FDA safety and performance requirements. Clinicians can rely on its regulatory clearance as evidence of compliance with U.S. standards for operating headlamps in eye care settings.