Visionary 2000

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

510(k) Number

K000639 ↗

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

• 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

• Genie Single Ceiling and Double Ceiling

  Class II

  FDA 510(k) K963682 Active Cleared 13 Nov 1996

• Saturn Light

  Class II

  FDA 510(k) K935102 Active Cleared 27 Jun 1994

See all devices from Burton Medical Products Corp. →

• What is the Visionary 2000 surgical light used for?

  The Visionary 2000 is a ceiling-mounted surgical light device designed to provide illumination during surgical procedures in general and plastic surgery settings in medical facilities.

• Is the Visionary 2000 single-use or reusable?

  The provided data does not specify whether the Visionary 2000 is designed for single-use or multiple reuse. This information would need to be confirmed directly with the manufacturer, Burton Medical Products Corp.

• What regulatory approvals does the Visionary 2000 have?

  The Visionary 2000 is authorized under FDA 510(k) clearance with product code FSY and regulation number 878.4580. It was cleared on May 25, 2000, and is intended for use in medical facilities.

• What sizes or models of the Visionary 2000 are available?

  The provided data does not specify different sizes or models of the Visionary 2000. For information about available configurations, it would be necessary to contact the manufacturer directly.