Panels › General, Plastic Surgery › Product code ONG · Class 2
Powered Laser Surgical Instrument With MicrobeamFractional Output
Regulation 878.4810
0510(k)s in 12 months (35 all time)
0recalls in 12 months (4 all time)
4recalls that name a 510(k)
Top companies in ONG
| Company | 510(k)s | Recalls |
|---|---|---|
| AVAVA, Inc. | 5 | 0 |
| Solta Medical, Inc. | 3 | 2 |
| Palomar Medical Products, Inc. | 3 | 0 |
| Ids, Ltd. | 1 | 1 |
| Lutronic Corporation | 2 | 0 |
| Palomar Medical Technologies, Inc. | 2 | 0 |
| Shanghai Apolo Medical Technology Co., Ltd. | 2 | 0 |
| Tria Beauty, Inc. | 2 | 0 |
| Wingderm Electro-Optics , Ltd. | 1 | 1 |
| Beijing Sincoheren Science and Technology Development Co. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 20, 2025 | K252155 | AVAVA Skin Treatment System AVAVA, Inc. | ONG |
| Jul 31, 2025 | K244060 | eCO2 3D Lutronic Corporation, KR | ONG |
| Jul 2, 2025 | K251031 | Fiber Laser Treatment Systems (HS-232,HS-233) Shanghai Apolo Medical Technology Co., Ltd., CN | ONG |
| Apr 14, 2025 | K250402 | AVAVA Skin Treatment System AVAVA, Inc. | ONG |
| Jan 2, 2024 | K233550 | MOSAIC 3D (Surgical Laser) Lutronic Aesthetic | ONG |
| Jun 22, 2023 | K223871 | Miria Skin Treatment System AVAVA, Inc. | ONG |
| Nov 21, 2022 | K221268 | SR-1 Skin Treatment System AVAVA, Inc. | ONG |
| Oct 13, 2022 | K221770 | Fiber Laser Treatment System Shanghai Apolo Medical Technology Co., Ltd., CN | ONG |
| Jun 3, 2022 | K213332 | Multifrax Laser System Paradigm Medical Corporation | ONG |
| Apr 13, 2021 | K202884 | SR-1 Skin Treatment System AVAVA, Inc. | ONG |
| Apr 30, 2020 | K192350 | Medical Non-Ablative Fractional Laser Systems Wingderm Electro-Optics , Ltd., CN | ONG |
| Nov 30, 2018 | K182498 | Advanced Skin Renewing Device Jiangsu Unimed Laser Technology Co., Ltd., CN | ONG |
| Feb 2, 2018 | K180036 | SMAXEL CO2 Surgical Laser System Ids, Ltd., KR | ONG |
| Jul 6, 2017 | K162398 | CO2 Laser Therapy Systems Beijing Sincoheren Science and Technology Development Co., CN | ONG |
| Dec 30, 2014 | K141868 | TRIA FANP Tria Beauty, Inc. | ONG |
| Dec 24, 2014 | K141046 | MIDI-SRS Srmc Co., Ltd. | ONG |
| Oct 25, 2013 | K130459 | TRIA FAN SYSTEM Tria Beauty, Inc. | ONG |
| Sep 19, 2013 | K131903 | EQUINOX CO2 LASER Eclipse Aesthetics, LLC | ONG |
| Sep 3, 2013 | K130028 | RESURFX 1565NM LASER MODULE Lumenis, Ltd., IL | ONG |
| Apr 12, 2012 | K110333 | NATURALASE CO2 LASER SYSTEM Focus Medical, LLC | ONG |
| Apr 2, 2012 | K120433 | CLEAR + BRILLIANT LASER SYSTEM Solta Medical, Inc. | ONG |
| Dec 19, 2011 | K111831 | MX-7000 MICROXEL Bio-Med USA, Inc. | ONG |
| Nov 14, 2011 | K111840 | EMERGE FRACTIONAL LASER Palomar Medical Products, Inc. | ONG |
| Jul 22, 2011 | K110984 | SLIM E30 II CO2 LASER Lasering S.R.L. | ONG |
| May 3, 2011 | K110349 | CLEAR+BRILLIANT LASER SYSTEM Solta Medical, Inc. | ONG |
| Mar 17, 2011 | K103664 | PRIMUS AESTHETIC PLATFORM Palomar Medical Technologies, Inc. | ONG |
| Jan 20, 2011 | K100610 | LUTRONIC CORPORATION ECO2 PLUS, DENTA III AND III+ AND SP III LASER SYSTEMS Lutronic Corporation | ONG |
| Nov 29, 2010 | K100487 | EQUINOX CO2 LASER SYSTEM Eclipsemed Global, Inc. | ONG |
| Nov 10, 2010 | K100590 | EDGE CO2 LASER SYSTEM Jm System Co., Ltd., KR | ONG |
| Sep 8, 2010 | K101490 | FRAXEL RE:STORE DUAL LASER SYSTEM: MODEL, MC-SYS-SR1500-D-US Thermage, Inc. | ONG |
| Sep 1, 2010 | K101506 | LUX1540, LUX1440 & LUX2940 LASER HANDPIECES Palomar Medical Technologies, Inc. | ONG |
| Oct 29, 2009 | K090639 | EXELO2, MODEL 4010 Quantel Derma GmbH | ONG |
| Oct 27, 2009 | K091446 | MODIFICATION TO LUX1540 HANDPIECE AND LUX 1440 HANDPIECE Palomar Medical Products, Inc. | ONG |
| Oct 14, 2009 | K091420 | FRAXEL RE: STORE LASER SYSTEM, MODEL SR1500 Solta Medical, Inc. | ONG |
| Jun 1, 2009 | K090525 | LOI SYSTEM Palomar Medical Products, Inc. | ONG |
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