Genie Single Ceiling and Double Ceiling

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K963682 ↗

FDA Product Code

FSY

Device Class

Class II

Regulation

21 CFR Part 878.4580

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Model 0450000, Opal Medical Exam Light

  Class I

  FDA 510(k) K893808 Active Cleared 15 Aug 1989

• Model 0183010, Pearl Medical Exam Light

  Class I

  FDA 510(k) K893807 Active Cleared 15 Aug 1989

• Visionary 2000

  Class II

  FDA 510(k) K000639 Active Cleared 25 May 2000

• Genesis

  Class II

  FDA 510(k) K942553 Active Cleared 23 Jun 1994

• Basic Light

  Class I

  FDA 510(k) K861289 Active Cleared 18 Apr 1986

• Saturn Light

  Class II

  FDA 510(k) K935102 Active Cleared 27 Jun 1994

See all devices from Burton Medical Products Corp. →

• Is the Genie Surgical Light reusable or single-use, and what does that mean for my facility’s maintenance routine?

  The Genie Single and Double Ceiling Surgical Light is designed as a reusable device, meaning it is intended for repeated use after proper cleaning, disinfection, and maintenance. Since it is non-sterile as supplied, your facility will need to establish protocols for decontamination between procedures to ensure safety and functionality. Burton Medical Products likely provides guidelines for cleaning and maintenance—check their documentation or contact their support team for specific instructions tailored to your model.

• What types of surgical procedures is this light system specifically designed to support, and how does the adjustable illumination help?

  The Genie Surgical Light is engineered to provide adjustable, focused illumination for a variety of surgical procedures, including general surgery, plastic surgery, and endoscopic surgeries. Its adjustable features allow surgeons to direct light precisely to the operative field, reducing glare and shadows while improving visibility—critical for delicate or intricate procedures where precision matters.

• Are there multiple configurations or accessories available for this device, and how do I determine which one fits my operating room setup?

  Yes, the Genie system includes multiple model variants, each corresponding to different configurations or accessories (as indicated by the diverse FEI numbers listed). These variants may include single-ceiling or double-ceiling mounts, additional lighting options, or other surgical-specific features. To select the right model, consult Burton Medical’s product catalog or contact their sales team—they can match your OR’s layout, ceiling height, and procedural needs to the appropriate variant.

• How is this device regulated, and what does the FDA’s 510(k) clearance mean for its use in my facility?

  The Genie Surgical Light holds an FDA 510(k) clearance (K963682), which means it has been determined to be substantially equivalent to a legally marketed device already on the market. This clearance confirms it meets FDA safety and performance standards for ceiling-mounted surgical lights. While clearance doesn’t imply endorsement for specific clinical uses, it does validate that the device adheres to regulatory requirements for design, manufacturing, and performance in controlled environments like operating rooms.

• Does the device come pre-installed, or is it supplied as a kit requiring installation by a technician?

  The Genie Surgical Light is supplied as a reusable system intended for installation in operating rooms or surgical settings. While the exact installation requirements aren’t detailed here, ceiling-mounted surgical lights typically require professional installation by a qualified electrician or medical equipment technician to ensure proper mounting, wiring, and compliance with facility standards. Burton Medical likely provides installation guidelines—verify these with their technical support or documentation before purchase.