FDA product code ONF: Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
ONF is the FDA product code for powered light based non-laser surgical instrument with thermal effect. It is a Class II device, regulated under 21 CFR 878.4810 and reviewed by the General and Plastic Surgery panel. FDA has cleared 74 510(k) submissions under ONF, 19 in the last five years, from 59 different applicants. The average 510(k) review took 141 days (median 112); 170 days on average over the last three years.
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.
Classification
| Field | Value |
|---|---|
| Device name | Powered Light Based Non-Laser Surgical Instrument With Thermal Effect |
| Device class | Class II |
| Regulation | 21 CFR 878.4810 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for ONF
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 2 | 56 |
| 2019 | 2 | 80 |
| 2020 | 4 | 96 |
| 2021 | 4 | 109 |
| 2022 | 4 | 172 |
| 2023 | 5 | 128 |
| 2024 | 5 | 150 |
| 2025 | 4 | 301 |
| 2026 | 1 | 60 |
Compare with all 510(k) review times · Search every ONF clearance
Top ONF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Shaser, Inc. | 9 | 2015-05-27 |
| El.En S.P.A. | 2 | 2025-02-26 |
| Smedtrum Medical Technology Co., Ltd. | 2 | 2024-05-17 |
| Beijing Adss Development Co., Ltd. | 2 | 2024-03-15 |
| Shangdong Huamei Technology Co., Ltd. | 2 | 2023-04-21 |
54 more applicants have ONF clearances. See the full list in Caduvo.
Most recent ONF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261204 | Sanhe LEFIS Electronics Co., Ltd. | Intense Pulsed Light Therapy Device | 2026-06-12 | 60 |
| K251545 | Micowey Medical Equipment (Guangxi) Co., Ltd. | Intense Pulsed Light Therapy Device (MMABM-1) | 2025-09-04 | 107 |
| K231952 | Medicreations, LLC | MEDILIGHT | 2025-09-03 | 796 |
| K243123 | Medusa (Guangxi)Medical Devices Co., Ltd. | IPL Treatment Device (MDSQMC-01) | 2025-07-03 | 276 |
| K250281 | El.En S.P.A. | DEKA LOTUS | 2025-02-26 | 26 |
Recalls for ONF devices
openFDA lists no recalls for product code ONF.
Frequently asked questions
What is FDA product code ONF?
ONF is the FDA product code for powered light based non-laser surgical instrument with thermal effect. It is a Class II device, regulated under 21 CFR 878.4810 and reviewed by the General and Plastic Surgery panel.
What device class is ONF?
Class II, regulation 21 CFR 878.4810. Typical premarket route: 510(k).
How long does a 510(k) take for product code ONF?
Across 74 cleared submissions the average was 141 days from receipt to decision (median 112).
Which companies have the most ONF clearances?
Shaser, Inc. (9); El.En S.P.A. (2); Smedtrum Medical Technology Co., Ltd. (2); Beijing Adss Development Co., Ltd. (2); Shangdong Huamei Technology Co., Ltd. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code ONF
- Run a recall and safety report across every ONF manufacturer
- Watch product code ONF for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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