Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
ONG · Predicate Candidate Screening
35 FDA 510(k) clearances under this product code; the 50 most recent screened below.
165 daysmedian FDA review time
283 days90th percentile
35clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252155 | AVAVA™ Skin Treatment System | AVAVA, Inc. | 2025-10-20 | 103 | 0 |
| K244060 | eCO2 3D | Lutronic Corporation | 2025-07-31 | 212 | 0 |
| K251031 | Fiber Laser Treatment Systems (HS-232,HS-233) | Shanghai Apolo Medical Technology Co., Ltd. | 2025-07-02 | 90 | 0 |
| K250402 | AVAVA™ Skin Treatment System | AVAVA, Inc. | 2025-04-14 | 61 | 0 |
| K233550 | MOSAIC 3D (Surgical Laser) | Lutronic Aesthetic | 2024-01-02 | 60 | 0 |
| K223871 | Miria Skin Treatment System | AVAVA, Inc. | 2023-06-22 | 181 | 0 |
| K221268 | SR-1 Skin Treatment System | AVAVA, Inc. | 2022-11-21 | 203 | 0 |
| K221770 | Fiber Laser Treatment System | Shanghai Apolo Medical Technology Co., Ltd. | 2022-10-13 | 114 | 0 |
| K213332 | Multifrax Laser System | Paradigm Medical Corporation | 2022-06-03 | 240 | 0 |
| K202884 | SR-1 Skin Treatment System | AVAVA, Inc. | 2021-04-13 | 197 | 0 |
| K192350 | Medical Non-Ablative Fractional Laser Systems | Wingderm Electro-Optics , Ltd. | 2020-04-30 | 245 | 1 |
| K182498 | Advanced Skin Renewing Device | Jiangsu Unimed Laser Technology Co., Ltd. | 2018-11-30 | 79 | 0 |
| K180036 | SMAXEL CO2 Surgical Laser System | Ids, Ltd. | 2018-02-02 | 28 | 1 |
| K162398 | CO2 Laser Therapy Systems | Beijing Sincoheren Science and Technology Development Co. | 2017-07-06 | 314 | 0 |
| K141868 | TRIA FANP | Tria Beauty, Inc. | 2014-12-30 | 173 | 0 |
| K141046 | MIDI-SRS | Srmc Co., Ltd. | 2014-12-24 | 245 | 0 |
| K130459 | TRIA FAN SYSTEM | Tria Beauty, Inc. | 2013-10-25 | 245 | 0 |
| K131903 | EQUINOX CO2 LASER | Eclipse Aesthetics, LLC | 2013-09-19 | 86 | 0 |
| K130028 | RESURFX 1565NM LASER MODULE | Lumenis, Ltd. | 2013-09-03 | 243 | 0 |
| K110333 | NATURALASE CO2 LASER SYSTEM | Focus Medical, LLC | 2012-04-12 | 434 | 0 |
| K120433 | CLEAR + BRILLIANT LASER SYSTEM | Solta Medical, Inc. | 2012-04-02 | 49 | 0 |
| K111831 | MX-7000 MICROXEL | Bio-Med USA, Inc. | 2011-12-19 | 174 | 0 |
| K111840 | EMERGE FRACTIONAL LASER | Palomar Medical Products, Inc. | 2011-11-14 | 138 | 0 |
| K110984 | SLIM E30 II CO2 LASER | Lasering S.R.L. | 2011-07-22 | 106 | 0 |
| K110349 | CLEAR+BRILLIANT LASER SYSTEM | Solta Medical, Inc. | 2011-05-03 | 85 | 0 |
| K103664 | PRIMUS AESTHETIC PLATFORM | Palomar Medical Technologies, Inc. | 2011-03-17 | 91 | 0 |
| K100610 | LUTRONIC CORPORATION ECO2 PLUS, DENTA III AND III+ AND SP II | Lutronic Corporation | 2011-01-20 | 323 | 0 |
| K100487 | EQUINOX CO2 LASER SYSTEM | Eclipsemed Global, Inc. | 2010-11-29 | 283 | 0 |
| K100590 | EDGE CO2 LASER SYSTEM | Jm System Co., Ltd. | 2010-11-10 | 253 | 0 |
| K101490 | FRAXEL RE:STORE DUAL LASER SYSTEM: MODEL, MC-SYS-SR1500-D-US | Thermage, Inc. | 2010-09-08 | 99 | 2 |
| K101506 | LUX1540, LUX1440 & LUX2940 LASER HANDPIECES | Palomar Medical Technologies, Inc. | 2010-09-01 | 92 | 0 |
| K090639 | EXELO2, MODEL 4010 | Quantel Derma GmbH | 2009-10-29 | 233 | 0 |
| K091446 | MODIFICATION TO LUX1540 HANDPIECE AND LUX 1440 HANDPIECE | Palomar Medical Products, Inc. | 2009-10-27 | 165 | 0 |
| K091420 | FRAXEL RE: STORE LASER SYSTEM, MODEL SR1500 | Solta Medical, Inc. | 2009-10-14 | 154 | 1 |
| K090525 | LOI SYSTEM | Palomar Medical Products, Inc. | 2009-06-01 | 95 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda