Medical Examination Lights

• • Terminated Z-0589-04 FDA Unclassified (pre-2012) ·initiated 19 Feb 2004

  Pivot joint on these ceiling mount lights may fail and lights may fall onto patients.

510(k) Number

K851742 ↗

FDA Product Code

KZF

Device Class

Class I

Regulation

21 CFR Part 880.6320

Advisory Committee

General Hospital

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

• Genie Single Ceiling and Double Ceiling

  Class II

  FDA 510(k) K963682 Active Cleared 13 Nov 1996

See all devices from Burton Medical Products Corp. →