Gyrus Plasma Skin Resurfacing System

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

510(k) Number

K023111 ↗

FDA Product Code

GEI

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Gyrus Endourology System: Axipolar Resectoscope Electrode

  Class II

  FDA 510(k) K994166 Active Cleared 27 Dec 1999

• Gyrus Open Forceps

  Class II

  FDA 510(k) K024286 Active Cleared 17 Nov 2003

• Everest LP Bipolar Scissors and Gyrus LP Bipolar Scissors

  Class II

  FDA 510(k) K031081 Active Cleared 21 May 2003

• Zip Open Forceps with Electrosurgical Cut

  Class II

  FDA 510(k) K020585 Active Cleared 13 Jul 2002

• Gyrus Plasma Skin Resurfacing System

  Class II

  FDA 510(k) K041999 Active Cleared 2 Mar 2005

• Plasmakinetic Endourology System

  Class II

  FDA 510(k) K003569 Active Cleared 19 Dec 2000

See all devices from Gyrus Medical, Ltd. →

• What types of skin irregularities is the Gyrus Plasma Skin Resurfacing System designed to address, and how does it work?

  The Gyrus Plasma Skin Resurfacing System is specifically designed to address superficial skin irregularities such as wrinkles, scars, and texture abnormalities. It uses plasma energy—generated by ionizing gas—to deliver precise thermal energy, which ablates the superficial skin layers and promotes controlled tissue regeneration. This process helps stimulate dermal remodeling, improving skin appearance by smoothing and refining the surface.

• Is the Gyrus Plasma Skin Resurfacing System intended for single-use or reusable applications, and how should it be handled?

  The Gyrus Plasma Skin Resurfacing System can be used either as a single-use or reusable device, depending on the manufacturer’s established protocols. Proper training is required for operation, and handling must follow sterile or non-sterile electrosurgical device protocols as specified by the manufacturer to ensure safety and efficacy.

• What regulatory pathway was followed for FDA clearance of this device, and which advisory committee was involved?

  The Gyrus Plasma Skin Resurfacing System received FDA clearance through a Traditional 510(k) pathway (K023111) and was determined to be Substantially Equivalent to a predicate device. The review was conducted under the General, Plastic Surgery advisory committee guidelines, specifically the SU (Skin and Ulcer) subcommittee, ensuring alignment with dermatological and plastic surgery procedures.

• What accessories are included with the Gyrus Plasma Skin Resurfacing System, and how is it supplied?

  The Gyrus Plasma Skin Resurfacing System is supplied as an electrosurgical generator with accessories, designed for dermatological procedures. While the exact accessories aren’t detailed here, the system is intended for use in controlled clinical settings where plasma energy is applied to skin for resurfacing. The manufacturer’s protocols dictate proper training and handling requirements.