Company ยท KR
Jeisys Medical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2008 to 2026. Name variants (Inc, Corp, punctuation) are merged.
19510(k) clearances (1 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 9 |
| GEX | Powered Laser Surgical Instrument | 6 |
| ILY | Lamp, Infrared, Therapeutic Heating | 1 |
| OHV | Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption | 1 |
| ONF | Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | 1 |
| OUH | Skin Resurfacing Rf Applicator | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 11, 2026 | K254185 | Potenza Prime Jeisys Medical Incorporated, KR | GEI |
| Oct 3, 2025 | K251464 | TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit) Jeisys Medical Incorporated, KR | GEX |
| Jul 8, 2025 | K250065 | DENSITY; DENZA; DENSITY Noir Jeisys Medical Incorporated, KR | GEI |
| Dec 10, 2024 | K231216 | POTENZA Jeisys Medical, Inc., KR | GEI |
| Nov 5, 2024 | K231287 | POTENZA Jeisys Medical, Inc., KR | GEI |
| Aug 14, 2023 | K230663 | Density Jeisys Medical, Inc., KR | GEI |
| Jan 4, 2023 | K223685 | SmoothCool HR System Jeisys Medical, Inc., KR | GEX |
| Apr 20, 2022 | K213484 | SmoothCool HR System Jeisys Medical, Inc., KR | GEX |
| Jan 19, 2021 | K201685 | Potenza Jeisys Medical, Inc., KR | GEI |
| Feb 20, 2020 | K192545 | Potenza Jeisys Medical Incorporated, KR | GEI |
| Jan 15, 2020 | K183284 | INTRAcel RF Microneedle System Jeisys Medical, Inc., KR | GEI |
| Oct 18, 2019 | K181896 | LIPOcel Jeisys Medical, Inc., KR | OHV |
| Oct 27, 2016 | K162169 | EdgeOne CO2 Laser Jeisys Medical, Inc., KR | GEX |
| Jul 21, 2016 | K153727 | INTRAcel Premium Fractional RF Micro Needle (FRM) System Jeisys Medical, Inc., KR | GEI |
| Jun 4, 2015 | K142833 | INTRAGen Jeisys Medical, Inc., KR | OUH |
| Jan 7, 2015 | K141861 | HILTHERA 4.0 Jeisys Medical, Inc. | ILY |
| Mar 5, 2010 | K092326 | SMOOTHCOOL Jeisys Medical, Inc. | ONF |
| Dec 19, 2008 | K082911 | SMOOTHCOOL HR SYSTEM Jeisys Medical, Inc. | GEX |
| Jan 24, 2008 | K072833 | P-NAIN SYSTEM Jeisys Medical, Inc. | GEX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||