ONG · Powered Laser Surgical Instrument With Microbeam\Fractional Output
General, Plastic Surgery · 21 CFR 878.4810 · Class 2
Overview
| Product Code | ONG |
|---|---|
| Device Name | Powered Laser Surgical Instrument With Microbeam\Fractional Output |
| Regulation | 21 CFR 878.4810 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
| 3rd-Party Reviewable | Yes |
Identification
(1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
Classification Rationale
(1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
Recent Cleared Devices (20 of 35)
Showing 20 most recent of 35 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252155 | AVAVA™ Skin Treatment System | AVAVA, Inc. | Oct 20, 2025 | SESE |
| K244060 | eCO2 3D | Lutronic Corporation | Jul 31, 2025 | SESE |
| K251031 | Fiber Laser Treatment Systems (HS-232,HS-233) | Shanghai Apolo Medical Technology Co., Ltd. | Jul 2, 2025 | SESE |
| K250402 | AVAVA™ Skin Treatment System | AVAVA, Inc. | Apr 14, 2025 | SESE |
| K233550 | MOSAIC 3D (Surgical Laser) | Lutronic Aesthetic | Jan 2, 2024 | SESE |
| K223871 | Miria Skin Treatment System | AVAVA, Inc. | Jun 22, 2023 | SESE |
| K221268 | SR-1 Skin Treatment System | AVAVA, Inc. | Nov 21, 2022 | SESE |
| K221770 | Fiber Laser Treatment System | Shanghai Apolo Medical Technology Co., Ltd. | Oct 13, 2022 | SESE |
| K213332 | Multifrax Laser System | Paradigm Medical Corporation | Jun 3, 2022 | SESE |
| K202884 | SR-1 Skin Treatment System | AVAVA, Inc. | Apr 13, 2021 | SESE |
| K192350 | Medical Non-Ablative Fractional Laser Systems | Wingderm Electro-Optics , Ltd. | Apr 30, 2020 | SESE |
| K182498 | Advanced Skin Renewing Device | Jiangsu Unimed Laser Technology Co., Ltd. | Nov 30, 2018 | SESE |
| K180036 | SMAXEL CO2 Surgical Laser System | Ids, Ltd. | Feb 2, 2018 | SESE |
| K162398 | CO2 Laser Therapy Systems | Beijing Sincoheren Science and Technology Development Co. | Jul 6, 2017 | SESE |
| K141868 | TRIA FANP | Tria Beauty, Inc. | Dec 30, 2014 | SESE |
| K141046 | MIDI-SRS | Srmc Co., Ltd. | Dec 24, 2014 | SESE |
| K130459 | TRIA FAN SYSTEM | Tria Beauty, Inc. | Oct 25, 2013 | SESE |
| K131903 | EQUINOX CO2 LASER | Eclipse Aesthetics, LLC | Sep 19, 2013 | SESE |
| K130028 | RESURFX 1565NM LASER MODULE | Lumenis, Ltd. | Sep 3, 2013 | SESE |
| K110333 | NATURALASE CO2 LASER SYSTEM | Focus Medical, LLC | Apr 12, 2012 | SESE |
Top Applicants
- AVAVA, Inc. — 5 clearances
- Palomar Medical Products, Inc. — 3 clearances
- Solta Medical, Inc. — 3 clearances
- Lutronic Corporation — 2 clearances
- Palomar Medical Technologies, Inc. — 2 clearances
