DeviceClearance

Product code ONF— General, Plastic Surgery

DEKA LOTUS

Classification name
Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
Device class
Class 2
Regulation
21 CFR 878.4810
Advisory panel
General, Plastic Surgery
Total cleared
74
First cleared
Most recent

FDA classification definition

“A light based non-laser device that provides thermal effect including broad spectrum source devices such as intense pulse light (ipl). Typically, indicated to be used in medical specialties of general and plastic surgery and of dermatology/aesthetic. 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, or remove tissue by the light.”

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

Market context for product code ONF

FDA has cleared 74 devices under product code ONF between 2008 and 2026, filed by 59 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

last 15 years

Top applicants under product code ONF

Recent clearances under product code ONF

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