ONG — Powered Laser Surgical Instrument With MicrobeamFractional Output Class II
Classification Details
- Product Code
- ONG
- Device Class
- Class II
- Regulation Number
- 878.4810
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K252155 | avava | AVAVA Skin Treatment System | October 20, 2025 |
| K244060 | lutronic corporation | eCO2 3D | July 31, 2025 |
| K251031 | shanghai apolo medical technology co | Fiber Laser Treatment Systems (HS-232,HS-233) | July 2, 2025 |
| K250402 | avava | AVAVA Skin Treatment System | April 14, 2025 |
| K233550 | lutronic aesthetic | MOSAIC 3D (Surgical Laser) | January 2, 2024 |
| K223871 | avava | Miria Skin Treatment System | June 22, 2023 |
| K221268 | avava | SR-1 Skin Treatment System | November 21, 2022 |
| K221770 | shanghai apolo medical technology co | Fiber Laser Treatment System | October 13, 2022 |
| K213332 | paradigm medical corporation | Multifrax Laser System | June 3, 2022 |
| K202884 | avava | SR-1 Skin Treatment System | April 13, 2021 |
| K192350 | wingderm electro-optics | Medical Non-Ablative Fractional Laser Systems | April 30, 2020 |
| K182498 | jiangsu unimed laser technology co | Advanced Skin Renewing Device | November 30, 2018 |
| K180036 | ids | SMAXEL CO2 Surgical Laser System | February 2, 2018 |
| K162398 | beijing sincoheren science and technology development | CO2 Laser Therapy Systems | July 6, 2017 |
| K141868 | tria beauty | TRIA FANP | December 30, 2014 |
| K141046 | srmc co | MIDI-SRS | December 24, 2014 |
| K130459 | tria beauty | TRIA FAN SYSTEM | October 25, 2013 |
| K131903 | eclipse aesthetics | EQUINOX CO2 LASER | September 19, 2013 |
| K130028 | lumenis | RESURFX 1565NM LASER MODULE | September 3, 2013 |
| K110333 | focus medical | NATURALASE CO2 LASER SYSTEM | April 12, 2012 |