Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Syneron Medical, Ltd. — Predicate Candidate Screening
35 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
99 daysmedian FDA review time
198 days90th percentile
35clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K170370 | ULTRASHAPE POWER SYSTEM | Syneron Medical, Ltd. | 2017-05-15 | 98 | 0 |
| K163415 | SlimShape System | Syneron Medical, Ltd. | 2017-04-20 | 136 | 0 |
| K162163 | UltraShape System | Syneron Medical, Ltd. | 2016-11-17 | 107 | 0 |
| K161952 | UltraShape System | Syneron Medical, Ltd. | 2016-11-07 | 115 | 0 |
| K160896 | ULTRASHAPE POWER SYSTEM | Syneron Medical, Ltd. | 2016-07-08 | 99 | 0 |
| K151655 | CO2RE System | Syneron Medical, Ltd. | 2015-09-15 | 89 | 0 |
| K141507 | TWO SKIN TREATMENT SYSTEM | Syneron Medical, Ltd. | 2014-12-08 | 185 | 0 |
| K141708 | ULTRASHAPE SYSTEM | Syneron Medical, Ltd. | 2014-10-06 | 104 | 0 |
| K133238 | CONTOUR I V3.1 SYSTEM | Syneron Medical, Ltd. | 2014-04-10 | 171 | 0 |
| K120510 | TRANSCEND | Syneron Medical, Ltd. | 2013-07-19 | 514 | 0 |
| K121598 | ME HAIR2GO | Syneron Medical, Ltd. | 2012-10-12 | 134 | 0 |
| K122579 | VELASHAPE | Syneron Medical, Ltd. | 2012-09-13 | 21 | 0 |
| K101321 | EMATRIX CO2 | Syneron Medical, Ltd. | 2010-11-09 | 182 | 0 |
| K090025 | MATRIX RF APPLICATOR | Syneron Medical, Ltd. | 2010-01-08 | 368 | 0 |
| K073572 | MATRIX RF APPLICATOR | Syneron Medical, Ltd. | 2008-09-17 | 273 | 0 |
| K073715 | ELIPO | Syneron Medical, Ltd. | 2008-04-23 | 114 | 0 |
| K071872 | VELASHAPE | Syneron Medical, Ltd. | 2007-08-22 | 47 | 0 |
| K070092 | MODIFICATION TO VELASMOOTH, SHAPER | Syneron Medical, Ltd. | 2007-07-27 | 198 | 0 |
| K053616 | POLARIS WR, ST APPLICATOR | Syneron Medical, Ltd. | 2006-03-14 | 76 | 0 |
| K052324 | POLARIS LV, LVA APPLICATOR | Syneron Medical, Ltd. | 2005-09-14 | 20 | 0 |
| K050397 | VELASMOOTH, SHAPER | Syneron Medical, Ltd. | 2005-06-09 | 113 | 0 |
| K050796 | AURORA DS, DS APPLICATOR | Syneron Medical, Ltd. | 2005-04-12 | 14 | 0 |
| K050452 | AURORA SR AND SRA APPLICATOR | Syneron Medical, Ltd. | 2005-03-09 | 15 | 0 |
| K041959 | POLARIS DS/COMET | Syneron Medical, Ltd. | 2004-11-08 | 110 | 0 |
| K041969 | AURORA DS | Syneron Medical, Ltd. | 2004-10-19 | 89 | 0 |
| K032514 | AC APPLICATOR, AURORA AC | Syneron Medical, Ltd. | 2004-01-27 | 166 | 0 |
| K033586 | MODIFICATION TO AURORA DS | Syneron Medical, Ltd. | 2003-12-10 | 27 | 0 |
| K031671 | POLARIS WR | Syneron Medical, Ltd. | 2003-12-01 | 186 | 0 |
| K031489 | PITANGA | Syneron Medical, Ltd. | 2003-08-19 | 99 | 0 |
| K031988 | AURORA DS | Syneron Medical, Ltd. | 2003-08-01 | 35 | 0 |
| K031993 | AURORA SR | Syneron Medical, Ltd. | 2003-08-01 | 35 | 0 |
| K030186 | POLRIS LV | Syneron Medical, Ltd. | 2003-04-14 | 83 | 0 |
| K024064 | POLARIS DS | Syneron Medical, Ltd. | 2003-02-10 | 63 | 0 |
| K022266 | AURORA SR | Syneron Medical, Ltd. | 2002-10-03 | 83 | 0 |
| K021149 | AURORA DS | Syneron Medical, Ltd. | 2002-07-09 | 90 | 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