Burane XL

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

510(k) Number

K050317 ↗

FDA Product Code

GEX

Device Class

Class II

Regulation

21 CFR Part 878.4810

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Wavelight Auriga

  Class II

  FDA 510(k) K051399 Active Cleared 30 Jun 2005

• Wavelight Sinon

  Class II

  FDA 510(k) K050218 Active Cleared 15 Feb 2005

• Sinon

  Class II

  FDA 510(k) K040433 Active Cleared 19 May 2004

• Arion

  Class II

  FDA 510(k) K042474 Active Cleared 29 Sep 2004

• Mydon C

  Class II

  FDA 510(k) K040384 Active Cleared 14 May 2004

• Burane

  Class II

  FDA 510(k) K052806 Active Cleared 17 Oct 2005

See all devices from Wavelight Laser Technologie AG →

• What types of skin treatments can the Burane XL laser system be used for according to its intended clinical applications?

  The Burane XL is designed for dermatological laser procedures, including skin resurfacing and tattoo removal. Its Er:YAG laser (2.94 µm wavelength) uses triple-mode technology to deliver precise ablation, coagulation, or a combination of both, making it suitable for aesthetic treatments where controlled tissue modification is required.

• Is the Burane XL laser system intended for single-use or reusable applications in a clinical setting?

  The Burane XL is supplied as a reusable medical laser system. Unlike disposable devices, it is meant to be used repeatedly in clinical settings by trained professionals, though standard infection control protocols must be followed during reuse.

• How is the Burane XL laser system regulated, and what does its FDA clearance indicate?

  The Burane XL holds FDA 510(k) clearance (K050317) under the General, Plastic Surgery advisory committee, classified as substantially equivalent to a prior device. This means it has been reviewed and determined to have the same intended use and technological characteristics as a legally marketed device, ensuring compliance with U.S. regulatory standards for laser systems in dermatology.

• What modes of treatment does the Burane XL laser system support, and how does this benefit clinical procedures?

  The Burane XL employs triple-mode technology, allowing it to deliver ablation (tissue removal), coagulation (tissue sealing), or a combined ablation-coagulation effect. This versatility enables clinicians to tailor treatments for specific dermatological needs, such as precise skin resurfacing or controlled tattoo pigment removal, depending on the procedure requirements.