Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Lutronic Corporation — Predicate Candidate Screening
29 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
154 daysmedian FDA review time
318 days90th percentile
29clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251327 | XERF | Lutronic Corporation | 2025-08-11 | 103 | 1 |
| K244060 | eCO2 3D | Lutronic Corporation | 2025-07-31 | 212 | 0 |
| K213748 | CoreLevee | Lutronic Corporation | 2022-10-14 | 318 | 0 |
| K213569 | HOLLYWOOD SPECTRA Laser System | Lutronic Corporation | 2022-02-04 | 87 | 0 |
| K203788 | DermaV Laser System | Lutronic Corporation | 2021-03-26 | 88 | 0 |
| K183566 | CLARITY II Laser System | Lutronic Corporation | 2019-06-14 | 175 | 1 |
| K180945 | LUTRONIC GENIUS Radiofrequency System | Lutronic Corporation | 2018-12-10 | 243 | 0 |
| K173700 | PICOPLUS Laser System | Lutronic Corporation | 2018-06-19 | 197 | 0 |
| K171009 | LASEMD Laser System | Lutronic Corporation | 2017-06-23 | 80 | 0 |
| K163196 | ACTION II Laser System | Lutronic Corporation | 2017-05-24 | 190 | 0 |
| K153769 | R:GEN Laser System | Lutronic Corporation | 2016-10-05 | 280 | 0 |
| K141555 | ADVANTAGE | Lutronic Corporation | 2014-11-06 | 147 | 0 |
| K130199 | CLARITY LPC LASER SYSTEM | Lutronic Corporation | 2013-11-22 | 298 | 0 |
| K121481 | INFINI RADIOFREQUENCY SYSTEM | Lutronic Corporation | 2013-06-25 | 403 | 0 |
| K113843 | FREEDOM ND: YAG LASER SYSTEM | Lutronic Corporation | 2012-09-27 | 274 | 0 |
| K113668 | HEALITE II SYSTEM | Lutronic Corporation | 2012-06-19 | 189 | 0 |
| K113502 | ADVANTAGE LASER SYSTEM | Lutronic Corporation | 2012-04-05 | 132 | 0 |
| K113588 | SPECTRA LASER SYSTEM | Lutronic Corporation | 2012-02-22 | 79 | 0 |
| K103455 | SPECTRA LASER SYSTEM | Lutronic Corporation | 2011-04-28 | 156 | 0 |
| K100610 | LUTRONIC CORPORATION ECO2 PLUS, DENTA III AND III+ AND SP II | Lutronic Corporation | 2011-01-20 | 323 | 0 |
| K101573 | ACCUSCULPT II LASER SYSTEM | Lutronic Corporation | 2010-09-23 | 108 | 0 |
| K091115 | ECO2 LASER SYSTEM | Lutronic Corporation | 2009-10-30 | 196 | 0 |
| K091320 | SPECTRA SP II, SPECTRA DENTA II | Lutronic Corporation | 2009-08-19 | 106 | 0 |
| K082096 | POWERLIPO LASER SYSTEM | Lutronic Corporation | 2008-10-08 | 76 | 0 |
| K080496 | MOSAIC ECO2 LASER SYSTEM | Lutronic Corporation | 2008-07-07 | 136 | 0 |
| K080932 | MOSAIC LASER SYSTEM | Lutronic Corporation | 2008-06-09 | 68 | 0 |
| K080248 | SPECTRA VRMIII Q-SWITCHED ND: YAG LASER SYSTEM AND DYE HANDP | Lutronic Corporation | 2008-04-23 | 83 | 0 |
| K073436 | SPECTRA VRMII 1-SWITCHED ND:YAG LASER SYSTEM | Lutronic Corporation | 2007-12-28 | 22 | 0 |
| K070392 | MOSAIC LASER SYSTEM | Lutronic Corporation | 2007-07-13 | 154 | 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