Pl Exam Light

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

510(k) Number

K860088 ↗

FDA Product Code

FTD

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

• 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. →

• What is the PL Exam Light used for?

  The PL Exam Light is used for examination purposes in general and plastic surgery settings, providing a reliable light source for medical professionals.

• Is the PL Exam Light authorized by the FDA?

  Yes, the PL Exam Light has been authorized with an FDA 510(k) clearance, specifically K860088, indicating its substantial equivalence to existing devices.

• What are the specifications of the PL Exam Light?

  The PL Exam Light has a product code of FTD and a regulation number of 878.4580, and is classified as a type of medical device used for examination purposes.