Omnilux Revive and Blue

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

510(k) Number

K043329 ↗

FDA Product Code

GEX

Device Class

Class II

Regulation

21 CFR Part 878.4810

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Omnilux New-U

  Class II

  FDA 510(k) K072459 Active Cleared 3 Mar 2008

• Omnilux Plus

  Class II

  FDA 510(k) K043317 Active Cleared 15 Mar 2005

• Omnilux Blue

  Class II

  FDA 510(k) K030883 Active Cleared 18 Jun 2003

• Omnilux Revive and Omnilux Plus

  Class II

  FDA 510(k) K050216 Active Cleared 9 Aug 2005

• Omnilux Red

  Class II

  FDA 510(k) K030426 Active Cleared 17 Jul 2003

• Omnilux Clear-U

  Class II

  FDA 510(k) K081307 Active Cleared 16 Jan 2009

• What is the Omnilux Revive and Blue used for?

  The Omnilux Revive and Blue is a Powered Laser Surgical Instrument designed for dermatological treatments in general and plastic surgery. It uses photobiomodulation to deliver targeted light therapy in the red and blue spectrums, helping address specific dermatological conditions. Its dual-wavelength capability sets it apart from single-wavelength lasers, allowing clinicians to tailor treatments to patient needs.

• Is the Omnilux Revive and Blue a single-use or reusable device?

  The Omnilux Revive and Blue is supplied as a reusable medical device. Since it is intended for clinical use in dermatological procedures, it must undergo proper maintenance and sterilization protocols to ensure safety and efficacy between uses. Reusability extends its utility in surgical settings where multiple patients may require treatment.

• What regulatory clearance does the Omnilux Revive and Blue hold?

  The Omnilux Revive and Blue holds FDA 510(k) clearance under the Traditional pathway, with a decision date of March 18, 2005. This clearance confirms that the device is substantially equivalent to a legally marketed predicate device for use in general and plastic surgery procedures. The product code assigned is GEX, indicating its classification.

• How should the Omnilux Revive and Blue be stored?

  While specific storage instructions are not detailed in the regulatory submission, reusable medical devices like the Omnilux Revive and Blue generally require protection from physical damage, contamination, and environmental factors such as extreme temperatures or humidity. Follow manufacturer guidelines for cleaning, maintenance, and storage to preserve functionality and ensure compliance with sterilization protocols before clinical use.

• Does the Omnilux Revive and Blue have an MRI safety classification?

  The regulatory submission for the Omnilux Revive and Blue does not specify an MRI safety classification. If MRI compatibility is a concern for your clinical setting, consult the manufacturer’s instructions or additional documentation to determine safe practices when using this device in proximity to MRI equipment.