Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
PKT — Predicate Candidate Screening
19 FDA 510(k) clearances under this product code; the 50 most recent screened below.
97 daysmedian FDA review time
405 days90th percentile
19clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K240658 | 1060nm laser body slimming machine | Hebei JT Medical Co., Ltd. | 2024-05-13 | 66 | 0 |
| K233962 | ReBorn (1050nm) | Lightfective , Ltd. | 2024-04-16 | 123 | 0 |
| K231971 | DEKA PHYSIQ 360 | El.En S.P.A. | 2023-09-26 | 85 | 0 |
| K231131 | Diode Laser Body Sculpture Systems | Shanghai Bele Medical Technology Co.,Ltd | 2023-06-22 | 62 | 0 |
| K222226 | EON | Dominion Aesthetic Technologies, Inc. | 2023-02-17 | 207 | 0 |
| K222265 | Diosculpt | Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd | 2022-09-23 | 57 | 0 |
| K211681 | EON | Dominion Aesthetic Technologies, Inc. | 2022-03-30 | 302 | 0 |
| K212331 | BodySculp | Rohrer Aesthetics, LLC | 2021-11-09 | 105 | 0 |
| K211402 | Powersculp laser lipolysis system | Lotuxs Medtech (Suzhou) Co., Ltd. | 2021-07-30 | 85 | 0 |
| K192970 | SLIMUS | Hironic Co., Ltd. | 2020-12-01 | 405 | 0 |
| K201731 | Diode Laser Body Sculpture System | Shanghai Apolo Medical Technology Co., Ltd. | 2020-09-10 | 78 | 0 |
| K191068 | Powersculp laser lipolysis system | Wuhan Lotuxs Technology Co., Ltd. | 2019-07-17 | 86 | 0 |
| K180511 | Eon FR | Dominion Aesthetic Technologies, Inc. | 2019-06-12 | 470 | 0 |
| K182741 | SculpSure | Cynosure | 2019-01-03 | 97 | 0 |
| K171992 | SculpSure | Cynosure, Inc. | 2017-09-26 | 85 | 0 |
| K171111 | Sculpsure | Cynosure, Inc. | 2017-06-13 | 60 | 0 |
| K160470 | SculpSure | Cynosure, Inc. | 2016-07-21 | 153 | 0 |
| K150724 | SculpSure | Cynosure, Inc. | 2015-07-01 | 103 | 0 |
| K150230 | SculpSure | Cynosure, Inc. | 2015-05-15 | 102 | 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