FDA 510(k) Applications for Medical Device Product Code "ONG"
(Powered Laser Surgical Instrument With Microbeam\Fractional Output)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K250402 | Avava Inc | AVAVAÖ Skin Treatment System | 04/14/2025 |
| K221268 | AVAVA, Inc | SR-1 Skin Treatment System | 11/21/2022 |
| K223871 | Avava, Inc. | Miria Skin Treatment System | 06/22/2023 |
| K202884 | AVAVA, Inc. | SR-1 Skin Treatment System | 04/13/2021 |
| K162398 | BEIJING SINCOHEREN SCIENCE AND TECHNOLOGY DEVELOPMENT CO. | CO2 Laser Therapy Systems | 07/06/2017 |
| K111831 | BIO-MED U.S.A., INC. | MX-7000 MICROXEL | 12/19/2011 |
| K131903 | ECLIPSE AESTHETICS, LLC | EQUINOX CO2 LASER | 09/19/2013 |
| K100487 | ECLIPSEMED GLOBAL, INC | EQUINOX CO2 LASER SYSTEM | 11/29/2010 |
| K110333 | FOCUS MEDICAL, LLC. | NATURALASE CO2 LASER SYSTEM | 04/12/2012 |
| K180036 | IDS, LTD. | SMAXEL CO2 Surgical Laser System | 02/02/2018 |
| K182498 | Jiangsu Unimed Laser Technology Co., Ltd. | Advanced Skin Renewing Device | 11/30/2018 |
| K100590 | JM SYSTEM CO., LTD. | EDGE CO2 LASER SYSTEM | 11/10/2010 |
| K110984 | LASERING S.R.L. | SLIM E30 II CO2 LASER | 07/22/2011 |
| K130028 | LUMENIS, LTD. | RESURFX 1565NM LASER MODULE | 09/03/2013 |
| K233550 | Lutronic Aesthetic | MOSAIC 3D (Surgical Laser) | 01/02/2024 |
| K100610 | LUTRONIC CORPORATION | LUTRONIC CORPORATION ECO2 PLUS, DENTA III AND III+ AND SP III LASER SYSTEMS | 01/20/2011 |
| K111840 | PALOMAR MEDICAL PRODUCTS, INC. | EMERGE FRACTIONAL LASER | 11/14/2011 |
| K090525 | PALOMAR MEDICAL PRODUCTS, INC. | LOI SYSTEM | 06/01/2009 |
| K091446 | PALOMAR MEDICAL PRODUCTS, INC. | MODIFICATION TO LUX1540 HANDPIECE AND LUX 1440 HANDPIECE | 10/27/2009 |
| K101506 | PALOMAR MEDICAL TECHNOLOGIES, INC. | LUX1540, LUX1440 & LUX2940 LASER HANDPIECES | 09/01/2010 |
| K103664 | PALOMAR MEDICAL TECHNOLOGIES, INC. | PRIMUS AESTHETIC PLATFORM | 03/17/2011 |
| K213332 | Paradigm Medical Corporation | Multifrax Laser System | 06/03/2022 |
| K090639 | QUANTEL DERMA GMBH | EXELO2, MODEL 4010 | 10/29/2009 |
| K221770 | Shanghai Apolo Medical Technology Co., Ltd. | Fiber Laser Treatment System | 10/13/2022 |
| K251031 | Shanghai Apolo Medical Technology Co., Ltd. | Fiber Laser Treatment Systems (HS-232,HS-233) | 07/02/2025 |
| K120433 | SOLTA MEDICAL, INC. | CLEAR + BRILLIANT LASER SYSTEM | 04/02/2012 |
| K110349 | SOLTA MEDICAL, INC. | CLEAR+BRILLIANT LASER SYSTEM | 05/03/2011 |
| K091420 | SOLTA MEDICAL, INC. | FRAXEL RE: STORE LASER SYSTEM, MODEL SR1500 | 10/14/2009 |
| K141046 | SRMC CO., LTD | MIDI-SRS | 12/24/2014 |
| K101490 | THERMAGE, INC. | FRAXEL RE:STORE DUAL LASER SYSTEM: MODEL, MC-SYS-SR1500-D-US | 09/08/2010 |
| K130459 | TRIA BEAUTY, INC. | TRIA FAN SYSTEM | 10/25/2013 |
| K141868 | TRIA BEAUTY, INC. | TRIA FANP | 12/30/2014 |
| K192350 | Wingderm Electro-Optics Ltd. | Medical Non-Ablative Fractional Laser Systems | 04/30/2020 |
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