Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
PDZ — Predicate Candidate Screening
19 FDA 510(k) clearances under this product code; the 50 most recent screened below.
186 daysmedian FDA review time
379 days90th percentile
19clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253960 | Medicell Mycosis Laser (MCML24004) | Medicell Healthcare Co.,LTD | 2026-03-09 | 89 | 0 |
| K241116 | Onycho Laser V | Terasysd&C, Inc. | 2024-07-22 | 90 | 0 |
| K211265 | TFX-LT2000 Therapy Light | Toefx, Inc. | 2022-11-17 | 570 | 0 |
| K221363 | AF Laser | ShenB Co., Ltd. | 2022-07-20 | 70 | 0 |
| K190034 | REMY Medical Therapy Laser System | Footdocprenur, LLC | 2019-05-15 | 128 | 0 |
| K153164 | LunulaLaser | Erchonia Medical, Inc. | 2016-06-03 | 214 | 0 |
| K150138 | Aspen Laser Systems Therapy Laser System | Aspen Laser Systems, LLC | 2015-05-08 | 106 | 0 |
| K123014 | LITECURE THERAPY SYSTEM MODEL LTS-1500 | Litecure, LLC | 2013-03-29 | 183 | 0 |
| K121508 | LIGHTWALKER AT LIGHTWALKER DT LIGHTWALKER ST-E LIGHTWALKER S | Fotona D.D. | 2012-12-12 | 205 | 0 |
| K113843 | FREEDOM ND: YAG LASER SYSTEM | Lutronic Corporation | 2012-09-27 | 274 | 0 |
| K120938 | THE PL-1064 LASER SYSTEM | Sheaumann Laser, Inc. | 2012-09-24 | 186 | 0 |
| K113702 | FOTONA XP ND: YAG LASER SYSTEM | Fotona D.D. | 2012-03-28 | 103 | 0 |
| K113810 | MODIFIED ALMA LASERS HARMONY 1064NM (ND:YAG) MODULES | Alma Lasers, Inc. | 2012-03-08 | 76 | 0 |
| K110375 | BLUESHINE'S GOLD SERIES | Blueshine Srl | 2012-02-23 | 379 | 0 |
| K111483 | JOULE CLEARSENSE LASER SYSTEM | Sciton, Inc | 2011-12-07 | 190 | 0 |
| K103338 | COOLTOUCH | New Star Lasers, Inc. | 2011-11-01 | 351 | 0 |
| K110370 | Q-CLEAR | Light Age, Inc. | 2011-09-15 | 219 | 0 |
| K103626 | CUTERA GENESISPLUS LASER SYSTEM | Cutera, Inc. | 2011-04-05 | 116 | 0 |
| K093547 | PINPOINTE FOOTLASER | Pinpointe USA, Inc. | 2010-10-15 | 332 | 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