Keeler Fiberoptic Headlamp

No FDA recalls found in the data synced 5 Oct 2026.

510(k) Number

K861747 ↗

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 is the Keeler Fiberoptic Headlamp used for?

  The Keeler Fiberoptic Headlamp is designed specifically for ophthalmic procedures requiring focused illumination, such as cataract surgery and retinal examinations. Its fiberoptic technology ensures high-quality, directed lighting to enhance surgical precision during delicate visual inspections.

• Is the Keeler Fiberoptic Headlamp reusable or single-use?

  This headlamp is supplied as a reusable instrument. Since it is non-sterile, it must be properly cleaned and maintained between uses in a clinical setting to ensure reliability and safety. Regular maintenance is essential to uphold its performance standards.

• What regulatory pathway does the Keeler Fiberoptic Headlamp follow?

  The Keeler Fiberoptic Headlamp is regulated under the FDA’s 510(k) clearance pathway with the reference number K861747. It was granted clearance through a traditional review process and is classified under 21 CFR 886.4335, adhering to standards for ophthalmic devices.

• How should the Keeler Fiberoptic Headlamp be stored?

  Since this device is reusable and non-sterile, it must be stored in a clean, dry environment when not in use. Proper storage helps prevent contamination and ensures the headlamp remains functional for future procedures. Follow manufacturer guidelines for cleaning and maintenance to extend its lifespan.

• Is the Keeler Fiberoptic Headlamp suitable for all ophthalmic surgeries?

  While the Keeler Fiberoptic Headlamp is designed for ophthalmic use, its primary applications are procedures requiring precise illumination, such as cataract surgery and retinal examinations. Clinicians should verify its compatibility with their specific surgical needs and consult the manufacturer’s instructions for optimal use.