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.
Cleared Devices (35)
| 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 |
| K120433 | CLEAR + BRILLIANT LASER SYSTEM | Solta Medical, Inc. | Apr 2, 2012 | SESE |
| K111831 | MX-7000 MICROXEL | Bio-Med USA, Inc. | Dec 19, 2011 | SESE |
| K111840 | EMERGE FRACTIONAL LASER | Palomar Medical Products, Inc. | Nov 14, 2011 | SESE |
| K110984 | SLIM E30 II CO2 LASER | Lasering S.R.L. | Jul 22, 2011 | SESE |
| K110349 | CLEAR+BRILLIANT LASER SYSTEM | Solta Medical, Inc. | May 3, 2011 | SESE |
| K103664 | PRIMUS AESTHETIC PLATFORM | Palomar Medical Technologies, Inc. | Mar 17, 2011 | SESE |
| K100610 | LUTRONIC CORPORATION ECO2 PLUS, DENTA III AND III+ AND SP III LASER SYSTEMS | Lutronic Corporation | Jan 20, 2011 | SESE |
| K100487 | EQUINOX CO2 LASER SYSTEM | Eclipsemed Global, Inc. | Nov 29, 2010 | SESE |
| K100590 | EDGE CO2 LASER SYSTEM | Jm System Co., Ltd. | Nov 10, 2010 | SESE |
| K101490 | FRAXEL RE:STORE DUAL LASER SYSTEM: MODEL, MC-SYS-SR1500-D-US | Thermage, Inc. | Sep 8, 2010 | SESE |
| K101506 | LUX1540, LUX1440 & LUX2940 LASER HANDPIECES | Palomar Medical Technologies, Inc. | Sep 1, 2010 | SESE |
| K090639 | EXELO2, MODEL 4010 | Quantel Derma GmbH | Oct 29, 2009 | SESE |
| K091446 | MODIFICATION TO LUX1540 HANDPIECE AND LUX 1440 HANDPIECE | Palomar Medical Products, Inc. | Oct 27, 2009 | SESE |
| K091420 | FRAXEL RE: STORE LASER SYSTEM, MODEL SR1500 | Solta Medical, Inc. | Oct 14, 2009 | SESE |
| K090525 | LOI SYSTEM | Palomar Medical Products, Inc. | Jun 1, 2009 | SESE |
Top Applicants
- AVAVA, Inc. — 5 clearances
- Solta Medical, Inc. — 3 clearances
- Palomar Medical Products, Inc. — 3 clearances
- Tria Beauty, Inc. — 2 clearances
- Shanghai Apolo Medical Technology Co., Ltd. — 2 clearances
