ONFClass II

Powered Light Based Non-Laser Surgical Instrument With Thermal Effect

21 CFR 878.4810 / General, Plastic Surgery

ONF is the FDA product code for Powered Light Based Non-Laser Surgical Instrument With Thermal Effect, a class II device type, regulated under 21 CFR 878.4810. FDA's definition for this code reads: "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...". As of 2026-09-10, FDA records hold 74 510(k) clearances under this code, the most recent dated 2026-06-12, and no recalls.

Classification record

Product code: ONF
Device name: Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
FDA 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.
Regulation: 21 CFR 878.4810
Device class: Class II
Review panel: General, Plastic Surgery
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 74
Ingested recalls: 0

Clearances, product code ONF

By decision year

74 clearances under product code ONF with a decision year between 2008 and 2026, 2013 the highest year at 10.

Show the numbers

510(k) clearances under FDA product code ONF by decision year
Year	Clearances
2008	1
2009	5
2010	4
2011	5
2012	3
2013	10
2014	7
2015	3
2016	5
2018	2
2019	2
2020	4
2021	4
2022	4
2023	5
2024	5
2025	4
2026	1

Applicants with the most clearances

Product code ONF

Applicants holding the most 510(k) clearances under product code ONF
Applicant	Clearances
Shaser, Inc.	9
Venus Concept Inc.	3
Beijing Adss Development Co., Ltd.	2
Beijing Globalipl Development Co., Ltd.	2
El.En S.p.A.	2
Shangdong Huamei Technology Co., Ltd.	2
Smedtrum Medical Technology Co. Ltd.	2
Syneron Beauty	2
Advanced Medical Photonics	1
Ahwon Medi Instrument Co., Ltd.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 96 companies shown, in name order