FDA Product Code
FDA Product Code ONG — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4810
510(k) Clearances — 35 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K252155 | AVAVA Skin Treatment System | AVAVA, Inc. | 2025-10-20 | Traditional | PDF ↗ |
| K244060 | eCO2 3D | Lutronic Corporation | 2025-07-31 | Traditional | PDF ↗ |
| K251031 | Fiber Laser Treatment Systems (HS-232,HS-233) | Shanghai Apolo Medical Technology Co., Ltd. | 2025-07-02 | Traditional | PDF ↗ |
| K250402 | AVAVA Skin Treatment System | AVAVA, Inc. | 2025-04-14 | Traditional | PDF ↗ |
| K233550 | MOSAIC 3D (Surgical Laser) | Lutronic Aesthetic | 2024-01-02 | Traditional | PDF ↗ |
| K223871 | Miria Skin Treatment System | AVAVA, Inc. | 2023-06-22 | Traditional | PDF ↗ |
| K221268 | SR-1 Skin Treatment System | AVAVA, Inc. | 2022-11-21 | Traditional | PDF ↗ |
| K221770 | Fiber Laser Treatment System | Shanghai Apolo Medical Technology Co., Ltd. | 2022-10-13 | Traditional | PDF ↗ |
| K213332 | Multifrax Laser System | Paradigm Medical Corporation | 2022-06-03 | Traditional | PDF ↗ |
| K202884 | SR-1 Skin Treatment System | AVAVA, Inc. | 2021-04-13 | Traditional | PDF ↗ |
| K192350 | Medical Non-Ablative Fractional Laser Systems | Wingderm Electro-Optics , Ltd. | 2020-04-30 | Traditional | PDF ↗ |
| K182498 | Advanced Skin Renewing Device | Jiangsu Unimed Laser Technology Co., Ltd. | 2018-11-30 | Traditional | PDF ↗ |
| K180036 | SMAXEL CO2 Surgical Laser System | Ids, Ltd. | 2018-02-02 | Special | PDF ↗ |
| K162398 | CO2 Laser Therapy Systems | Beijing Sincoheren Science and Technology Development Co. | 2017-07-06 | Traditional | PDF ↗ |
| K141868 | TRIA FANP | Tria Beauty, Inc. | 2014-12-30 | Traditional | PDF ↗ |
| K141046 | MIDI-SRS | Srmc Co., Ltd. | 2014-12-24 | Traditional | PDF ↗ |
| K130459 | TRIA FAN SYSTEM | Tria Beauty, Inc. | 2013-10-25 | Traditional | PDF ↗ |
| K131903 | EQUINOX CO2 LASER | Eclipse Aesthetics, LLC | 2013-09-19 | Special | PDF ↗ |
| K130028 | RESURFX 1565NM LASER MODULE | Lumenis, Ltd. | 2013-09-03 | Traditional | PDF ↗ |
| K110333 | NATURALASE CO2 LASER SYSTEM | Focus Medical, LLC | 2012-04-12 | Traditional | PDF ↗ |
| K120433 | CLEAR + BRILLIANT LASER SYSTEM | Solta Medical, Inc. | 2012-04-02 | Special | PDF ↗ |
| K111831 | MX-7000 MICROXEL | Bio-Med USA, Inc. | 2011-12-19 | Traditional | PDF ↗ |
| K111840 | EMERGE FRACTIONAL LASER | Palomar Medical Products, Inc. | 2011-11-14 | Traditional | PDF ↗ |
| K110984 | SLIM E30 II CO2 LASER | Lasering S.R.L. | 2011-07-22 | Special | PDF ↗ |
| K110349 | CLEAR+BRILLIANT LASER SYSTEM | Solta Medical, Inc. | 2011-05-03 | Traditional | PDF ↗ |
| K103664 | PRIMUS AESTHETIC PLATFORM | Palomar Medical Technologies, Inc. | 2011-03-17 | Special | PDF ↗ |
| K100610 | LUTRONIC CORPORATION ECO2 PLUS, DENTA III AND III+ AND SP III LASER SYSTEMS | Lutronic Corporation | 2011-01-20 | Traditional | PDF ↗ |
| K100487 | EQUINOX CO2 LASER SYSTEM | Eclipsemed Global, Inc. | 2010-11-29 | Traditional | PDF ↗ |
| K100590 | EDGE CO2 LASER SYSTEM | Jm System Co., Ltd. | 2010-11-10 | Traditional | PDF ↗ |
| K101490 | FRAXEL RE:STORE DUAL LASER SYSTEM: MODEL, MC-SYS-SR1500-D-US | Thermage, Inc. | 2010-09-08 | Traditional | PDF ↗ |
| K101506 | LUX1540, LUX1440 & LUX2940 LASER HANDPIECES | Palomar Medical Technologies, Inc. | 2010-09-01 | Traditional | PDF ↗ |
| K090639 | EXELO2, MODEL 4010 | Quantel Derma GmbH | 2009-10-29 | Traditional | PDF ↗ |
| K091446 | MODIFICATION TO LUX1540 HANDPIECE AND LUX 1440 HANDPIECE | Palomar Medical Products, Inc. | 2009-10-27 | Special | PDF ↗ |
| K091420 | FRAXEL RE: STORE LASER SYSTEM, MODEL SR1500 | Solta Medical, Inc. | 2009-10-14 | Traditional | PDF ↗ |
| K090525 | LOI SYSTEM | Palomar Medical Products, Inc. | 2009-06-01 | Traditional | PDF ↗ |
Product code ONG · Class II · General, Plastic Surgery. Data: openFDA.