DeviceClearance

Product code ONG— General, Plastic Surgery

AVAVA Skin Treatment System

Classification name
Powered Laser Surgical Instrument With MicrobeamFractional Output
Device class
Class 2
Regulation
21 CFR 878.4810
Advisory panel
General, Plastic Surgery
Total cleared
35
First cleared
Most recent

FDA classification definition

“A LASER (Light Amplification by Stimulated Emission of Radiation) based device having coherence, collimated and typically monochromatic radiation. The laser output is in form of tiny beams in micro range. Typically, indicated to be used in medical specialties of general and plastic surgery and of dermatology/aesthetic to destroy, remove or coagulate tissue, generally soft tissue. Indication for Use can be general and/or specific. The classification regulation 21 CFR 878.4810 describes a device that is carbon dioxide or argon laser intended to cut, destroy, remove or coagulate tissue by the light.”

— U.S. Food and Drug Administration, device classification record for product code ONG under 21 CFR 878.4810, via openFDA

Market context for product code ONG

FDA has cleared 35 devices under product code ONG between 2009 and 2025, filed by 23 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code ONG

Recent clearances under product code ONG

Data sourced from openFDA. This site is unofficial and independent of the FDA.