Illuminator IV Minor Surgery Light

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

510(k) Number

K922279 ↗

FDA Product Code

FSW

Device Class

Class II

Regulation

21 CFR Part 878.4580

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Illuminator III

  Class I

  FDA 510(k) K922278 Active Cleared 4 Mar 1993

• Mi-4 Variable Spot Light

  Class I

  FDA 510(k) K931646 Active Cleared 19 Aug 1993

• Illuminator VII Mini/Lum Light

  Class I

  FDA 510(k) K922280 Active Cleared 5 Feb 1993

• Mi-5 Diagnostic Light

  Class I

  FDA 510(k) K931026 Active Cleared 19 Aug 1993

• Mi-15 Exam Surgical Light

  Class II

  FDA 510(k) K930897 Active Cleared 25 Jun 1993

• M.E.D. Light

  Class I

  FDA 510(k) K925710 Active Cleared 4 Jun 1993

See all devices from Medical Illumination, Inc. →

• What is the Illuminator IV Minor Surgery Light used for?

  The Illuminator IV Minor Surgery Light is intended for use as a surgical light source in general and plastic surgery procedures, specifically designed to provide illumination during minor surgery in surgical settings.

• How is the Illuminator IV Minor Surgery Light supplied or configured for use?

  The device is supplied as a surgical light unit intended for installation and use in surgical environments, providing focused illumination for minor surgical procedures as a standalone light source.

• Is the Illuminator IV Minor Surgery Light a single-use or reusable device?

  The Illuminator IV Minor Surgery Light is a reusable device designed for repeated use in surgical settings; it is not intended to be single-use and requires proper cleaning and maintenance between uses.

• What regulatory pathway was used for the Illuminator IV Minor Surgery Light?

  The Illuminator IV Minor Surgery Light received FDA 510(k) clearance under submission K922279, demonstrating substantial equivalence to a predicate device, and is classified as a Class II device under regulation 878.4580.