Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Alma Lasers , Ltd. — Predicate Candidate Screening
14 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
163 daysmedian FDA review time
326 days90th percentile
14clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K212073 | Alma Diode Tabletop Laser | Alma Lasers , Ltd. | 2022-07-14 | 377 | 0 |
| K203441 | The Alma Hybrid Laser System | Alma Lasers , Ltd. | 2021-07-02 | 221 | 0 |
| K170850 | Alma Q | Alma Lasers , Ltd. | 2017-06-15 | 85 | 0 |
| K140009 | SOPRANO ICE MULTI-APPLICATION & MULTI-TECHNOLOGY PLATFORM | Alma Lasers , Ltd. | 2014-08-29 | 239 | 0 |
| K140005 | ALMA DIODE TABLETOP LASER | Alma Lasers , Ltd. | 2014-07-18 | 197 | 0 |
| K090571 | ALMA LASERS ALEX755 MODULE | Alma Lasers , Ltd. | 2009-08-13 | 163 | 0 |
| K083848 | ALMA LASERS SOPRANO XL MULTI-APPLICATION PLATFORM | Alma Lasers , Ltd. | 2009-04-14 | 111 | 0 |
| K082622 | ALMA LASERS ACCENT B-SHAPE MASSAGER HANDPIECE/MODULE | Alma Lasers , Ltd. | 2009-01-12 | 125 | 0 |
| K080463 | ALMA LASERS THERMOXEL CO2 LASER SYSTEM AND DELIVERY DEVICE A | Alma Lasers , Ltd. | 2008-07-23 | 154 | 0 |
| K072182 | ALMA LASERS FAMILY OF THERMO-XEL HANDPIECES, PIXEL MODELS: 2 | Alma Lasers , Ltd. | 2008-06-27 | 326 | 0 |
| K072564 | ALMA LASERS HARMONY XL MULTI-APPLICATION PLATFORM | Alma Lasers , Ltd. | 2008-05-23 | 255 | 0 |
| K080318 | ALMA LASER NIR MODULE | Alma Lasers , Ltd. | 2008-03-07 | 30 | 0 |
| K072699 | ALMA LASERS FAMILY OF ACCENT RADIOFREQUENCY (RF) SYSTEMS, MO | Alma Lasers , Ltd. | 2007-10-05 | 11 | 0 |
| K070004 | ACCENT | Alma Lasers , Ltd. | 2007-04-23 | 110 | 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