Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Jeisys Medical, Inc. · Predicate Candidate Screening
15 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
206 daysmedian FDA review time
551 days90th percentile
15clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K231216 | POTENZA | Jeisys Medical, Inc. | 2024-12-10 | 592 | 0 |
| K231287 | POTENZA | Jeisys Medical, Inc. | 2024-11-05 | 551 | 0 |
| K230663 | Density | Jeisys Medical, Inc. | 2023-08-14 | 157 | 0 |
| K223685 | SmoothCool HR System | Jeisys Medical, Inc. | 2023-01-04 | 26 | 0 |
| K213484 | SmoothCool HR System | Jeisys Medical, Inc. | 2022-04-20 | 173 | 0 |
| K201685 | Potenza | Jeisys Medical, Inc. | 2021-01-19 | 211 | 0 |
| K183284 | INTRAcel RF Microneedle System | Jeisys Medical, Inc. | 2020-01-15 | 415 | 0 |
| K181896 | LIPOcel | Jeisys Medical, Inc. | 2019-10-18 | 459 | 0 |
| K162169 | EdgeOne CO2 Laser | Jeisys Medical, Inc. | 2016-10-27 | 85 | 0 |
| K153727 | INTRAcel Premium Fractional RF Micro Needle (FRM) System | Jeisys Medical, Inc. | 2016-07-21 | 206 | 0 |
| K142833 | INTRAGen | Jeisys Medical, Inc. | 2015-06-04 | 247 | 0 |
| K141861 | HILTHERA 4.0 | Jeisys Medical, Inc. | 2015-01-07 | 181 | 0 |
| K092326 | SMOOTHCOOL | Jeisys Medical, Inc. | 2010-03-05 | 213 | 0 |
| K082911 | SMOOTHCOOL HR SYSTEM | Jeisys Medical, Inc. | 2008-12-19 | 80 | 0 |
| K072833 | P-NAIN SYSTEM | Jeisys Medical, Inc. | 2008-01-24 | 113 | 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