FDA product code ONG: Powered Laser Surgical Instrument With MicrobeamFractional Output
ONG is the FDA product code for powered laser surgical instrument with microbeamfractional output. It is a Class II device, regulated under 21 CFR 878.4810 and reviewed by the General and Plastic Surgery panel. FDA has cleared 35 510(k) submissions under ONG, 9 in the last five years, from 23 different applicants. The average 510(k) review took 168 days (median 165); 88 days on average over the last three years. FDA has posted 4 recalls for ONG devices, 2 initiated in the last five years.
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.
Classification
| Field | Value |
|---|---|
| Device name | Powered Laser Surgical Instrument With MicrobeamFractional Output |
| 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 ONG
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 314 |
| 2018 | 2 | 54 |
| 2020 | 1 | 245 |
| 2021 | 1 | 197 |
| 2022 | 3 | 186 |
| 2023 | 1 | 181 |
| 2024 | 1 | 60 |
| 2025 | 4 | 116 |
Compare with all 510(k) review times · Search every ONG clearance
Top ONG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| AVAVA, Inc. | 5 | 2025-10-20 |
| Solta Medical, Inc. | 3 | 2012-04-02 |
| Palomar Medical Products, Inc. | 3 | 2011-11-14 |
| Lutronic Corporation | 2 | 2025-07-31 |
| Shanghai Apolo Medical Technology Co., Ltd. | 2 | 2025-07-02 |
18 more applicants have ONG clearances. See the full list in Caduvo.
Most recent ONG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252155 | AVAVA, Inc. | AVAVA Skin Treatment System | 2025-10-20 | 103 |
| K244060 | Lutronic Corporation | eCO2 3D | 2025-07-31 | 212 |
| K251031 | Shanghai Apolo Medical Technology Co., Ltd. | Fiber Laser Treatment Systems (HS-232,HS-233) | 2025-07-02 | 90 |
| K250402 | AVAVA, Inc. | AVAVA Skin Treatment System | 2025-04-14 | 61 |
| K233550 | Lutronic Aesthetic | MOSAIC 3D (Surgical Laser) | 2024-01-02 | 60 |
Recalls for ONG devices
4 product recalls in 4 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2024-10-16.
| Year | Recalls |
|---|---|
| 2024 | 2 |
Frequently asked questions
What is FDA product code ONG?
ONG is the FDA product code for powered laser surgical instrument with microbeamfractional output. 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 ONG?
Class II, regulation 21 CFR 878.4810. Typical premarket route: 510(k).
How long does a 510(k) take for product code ONG?
Across 35 cleared submissions the average was 168 days from receipt to decision (median 165).
Which companies have the most ONG clearances?
AVAVA, Inc. (5); Solta Medical, Inc. (3); Palomar Medical Products, Inc. (3); Lutronic Corporation (2); Shanghai Apolo Medical Technology Co., Ltd. (2).
Have ONG devices been recalled?
Yes: 4 product recalls across 4 recall events; the most recent began 2024-10-16.
Next steps
- Run an FDA pathway report with predicate devices for product code ONG
- Run a recall and safety report across every ONG manufacturer
- Watch product code ONG 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.
All General and Plastic Surgery product codes · FDA product code lookup · 510(k) database search · 510(k) review times