Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cutera, Inc. — Predicate Candidate Screening
31 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
87 daysmedian FDA review time
249 days90th percentile
31clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251149 | AviClear Laser System | Cutera, Inc. | 2025-07-11 | 88 | 0 |
| K233237 | xeo+ Family | Cutera, Inc. | 2023-12-15 | 78 | 0 |
| K230660 | AviClear Laser System | Cutera, Inc. | 2023-06-06 | 88 | 0 |
| K223110 | truSculpt iD | Cutera, Inc. | 2022-11-03 | 31 | 0 |
| K221407 | truSculpt iD | Cutera, Inc. | 2022-07-13 | 58 | 0 |
| K213461 | AviClear Laser System | Cutera, Inc. | 2022-03-24 | 148 | 0 |
| K182997 | enlighten III Laser System | Cutera, Inc. | 2018-12-12 | 43 | 0 |
| K180709 | truSculpt RF Device; truSculpt; truSculpt 3D | Cutera, Inc. | 2018-06-06 | 79 | 0 |
| K172077 | Cutera enlighten III Laser System | Cutera, Inc. | 2017-10-27 | 109 | 0 |
| K172004 | truSculpt | Cutera, Inc. | 2017-08-02 | 30 | 0 |
| K170936 | Cutera enlighten III Laser System | Cutera, Inc. | 2017-04-25 | 26 | 0 |
| K162512 | truSculpt | Cutera, Inc. | 2016-12-09 | 92 | 0 |
| K160488 | Cutera enlighten III Laser System | Cutera, Inc. | 2016-10-28 | 249 | 0 |
| K153671 | Family of CoolGlide Aesthetic Lasers | Cutera, Inc. | 2016-03-09 | 79 | 0 |
| K140727 | CUTERA PICOSECOND LASER SYSTEM | Cutera, Inc. | 2014-11-06 | 227 | 0 |
| K133739 | TRUSCULPT | Cutera, Inc. | 2014-09-05 | 270 | 0 |
| K133945 | CUTERA PICOSECOND LASER SYSTEM | Cutera, Inc. | 2014-08-11 | 231 | 0 |
| K132185 | FAMILY OF COOLGLIDE AESTHETIC LASERS | Cutera, Inc. | 2013-12-06 | 144 | 0 |
| K122493 | GENESISPLUS | Cutera, Inc. | 2013-05-15 | 272 | 0 |
| K122389 | TRUSCULPT | Cutera, Inc. | 2012-11-02 | 87 | 1 |
| K102954 | CUTERA QSWITCH LASER SYSTEM | Cutera, Inc. | 2011-06-22 | 260 | 0 |
| K103626 | CUTERA GENESISPLUS LASER SYSTEM | Cutera, Inc. | 2011-04-05 | 116 | 0 |
| K092195 | CUTERA MULTIMODAL CELLULITE PRODUCT (CMMCD) | Cutera, Inc. | 2009-10-01 | 72 | 0 |
| K080530 | MODIFICATION TO CUTERA ER:YSGG LASER HANDPIECE | Cutera, Inc. | 2008-08-15 | 171 | 0 |
| K080300 | CUTERA MULTIMODAL CELLULITE PRODUCT (CMMCD) | Cutera, Inc. | 2008-04-08 | 63 | 0 |
| K063867 | CUTERA ER:YSGG LASER HANDPIECE | Cutera, Inc. | 2007-03-27 | 88 | 0 |
| K070138 | CUTERA ER:YAG LASER HANDPIECE | Cutera, Inc. | 2007-03-27 | 70 | 0 |
| K050679 | CUTERA SOLERA OPUS AESTHETIC PRODUCT | Cutera, Inc. | 2005-03-31 | 15 | 0 |
| K050047 | CUTERA OPTIONAL PULSED LIGHT HAND PIECE FAMILY | Cutera, Inc. | 2005-03-31 | 80 | 0 |
| K050069 | CUTERA FLASHLAMP TABLETOP AESTHETIC PRODUCT | Cutera, Inc. | 2005-01-31 | 19 | 0 |
| K042165 | CUTERA TABLETOP AESTHETIC PRODUCT | Cutera, Inc. | 2004-10-18 | 68 | 1 |
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