Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Alma Lasers, Inc. — Predicate Candidate Screening
20 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
91 daysmedian FDA review time
368 days90th percentile
20clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251684 | Alma TED+ System | Alma Lasers, Inc. | 2026-06-05 | 368 | 0 |
| K250071 | Alma FemiLift Pixel CO2 Laser System, Delivery Devices and A | Alma Lasers, Inc. | 2025-09-24 | 257 | 0 |
| K251230 | The Alma Hybrid Laser System | Alma Lasers, Inc. | 2025-05-21 | 30 | 0 |
| K243044 | Alma Harmony | Alma Lasers, Inc. | 2025-04-11 | 196 | 0 |
| K233024 | Alma Harmony | Alma Lasers, Inc. | 2024-02-08 | 139 | 0 |
| K230308 | Alma Harmony | Alma Lasers, Inc. | 2023-03-01 | 26 | 0 |
| K230371 | The Alma Soprano Titanium | Alma Lasers, Inc. | 2023-02-22 | 9 | 0 |
| K222064 | The Alma Soprano Titanium | Alma Lasers, Inc. | 2022-10-12 | 91 | 0 |
| K201520 | The Alma Opus System, Colibri Applicator and Tips | Alma Lasers, Inc. | 2021-10-27 | 506 | 0 |
| K181298 | Harmony XL Multi-Application Platform | Alma Lasers, Inc. | 2018-06-13 | 28 | 0 |
| K172193 | Modified Alma Lasers Soprano XL™ Family ofMulti-Application | Alma Lasers, Inc. | 2018-01-09 | 172 | 0 |
| K171242 | Alma LipoFlow System | Alma Lasers, Inc. | 2017-07-14 | 78 | 0 |
| K170626 | Modified Alma Lasers Soprano XL Family of Multi-Application | Alma Lasers, Inc. | 2017-05-31 | 90 | 0 |
| K160075 | Accent XL | Alma Lasers, Inc. | 2016-08-17 | 216 | 0 |
| K121150 | ALMA LASERS FAMILY OF PIXEL RF TIPS | Alma Lasers, Inc. | 2012-09-21 | 158 | 0 |
| K113810 | MODIFIED ALMA LASERS HARMONY 1064NM (ND:YAG) MODULES | Alma Lasers, Inc. | 2012-03-08 | 76 | 0 |
| K112031 | ALMA LASERS MODIFIED DIODE LASER MODULE WITH SHR TREATMENT M | Alma Lasers, Inc. | 2011-09-13 | 60 | 0 |
| K101147 | MODIFIED ALMA LASERS FAMILY OF ACCENT RADIOFREQUENCY (RF) SY | Alma Lasers, Inc. | 2011-01-21 | 273 | 0 |
| K103501 | ALMA LASERS PIXEL CO2 LASER SYSTEM, DELIVERY DEVICE AND ACCE | Alma Lasers, Inc. | 2011-01-14 | 46 | 0 |
| K102716 | MODIFIED ALMA LASERS FAMILY OF SOPRANO XL MULTI-APPLICATION | Alma Lasers, Inc. | 2010-09-28 | 7 | 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