Xenon Light Source

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K904609 ↗

FDA Product Code

HBI

Device Class

Class II

Regulation

21 CFR Part 878.4580

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• True Vision, True Vision II

  Class I

  FDA 510(k) K974542 Active Cleared 17 Feb 1998

• Optical Catheter Introducer Sets, Modification

  Class I

  FDA 510(k) K914315 Active Cleared 4 Mar 1992

• Adair/Veress Needle Introducer Set

  Class I

  FDA 510(k) K930568 Active Cleared 22 Jul 1993

• Optical Catheter(Tm) Introducer Sets

  Class I

  FDA 510(k) K895041 Active Cleared 16 Oct 1989

• Over the Wire Stone Basket

  Class II

  FDA 510(k) K915538 Active Cleared 20 Mar 1992

• Medical Dynamics Light Source

  Class II

  FDA 510(k) K894319 Active Cleared 3 Oct 1989

See all devices from Medical Dynamics, Inc. →

• What is the Xenon Light Source used for?

  The Xenon Light Source is an illuminator device specifically designed for surgical field illumination, providing bright, consistent lighting during medical procedures in general and plastic surgery settings.

• Is the Xenon Light supplied sterile?

  The device data does not specify whether the Xenon Light Source is supplied sterile. No information regarding sterility is provided in the available documentation.

• Is the Xenon Light Source single-use or reusable?

  The device data does not specify whether the Xenon Light Source is single-use or reusable. No information regarding its usage classification is provided in the available documentation.

• What regulatory approvals does the Xenon Light Source have?

  The Xenon Light Source has FDA 510(k) clearance with product code HBI, as filed by Medical Dynamics, Inc. It was determined to be substantially equivalent to predicate devices for general and plastic surgery use.