Jeisys Medical, Inc.: FDA filings under this applicant name
FDA lists 15 510(k) clearances under the applicant name “Jeisys Medical, Inc.” (first 2008, latest 2024), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 206 days. Since 2017 the median was 313 days, against 98 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 2 | 214 |
| 2016 | 2 | 146 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 1 | 459 |
| 2020 | 1 | 415 |
| 2021 | 1 | 211 |
| 2022 | 1 | 173 |
| 2023 | 2 | 92 |
| 2024 | 2 | 572 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Jeisys Medical, Inc. took a median 313 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 98 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 6 | 6 |
| GEX | Powered Laser Surgical Instrument | 5 | 5 |
| ILY | Lamp, Infrared, Therapeutic Heating | 1 | 1 |
| OHV | Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption | 1 | 1 |
| ONF | Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | 1 | 1 |
| OUH | Skin Resurfacing Rf Applicator | 1 | 1 |
Review panels
Most recent Jeisys Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K231216 | POTENZA | GEI | 2024-12-10 | 592 |
| K231287 | POTENZA | GEI | 2024-11-05 | 551 |
| K230663 | Density | GEI | 2023-08-14 | 157 |
| K223685 | SmoothCool HR System | GEX | 2023-01-04 | 26 |
| K213484 | SmoothCool HR System | GEX | 2022-04-20 | 173 |
| K201685 | Potenza | GEI | 2021-01-19 | 211 |
| K183284 | INTRAcel RF Microneedle System | GEI | 2020-01-15 | 415 |
| K181896 | LIPOcel | OHV | 2019-10-18 | 459 |
| K162169 | EdgeOne CO2 Laser | GEX | 2016-10-27 | 85 |
| K153727 | INTRAcel Premium Fractional RF Micro Needle (FRM) System | GEI | 2016-07-21 | 206 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Jeisys Medical, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Jeisys Medical, Inc. is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT06457607: Evaluating the Efficacy and Safety of Treatment With LinearFirm(ULTRAcel Q+) in Temporary Eyebrow Lifting (Completed, started 2023-02-24)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Jeisys Medical Incorporated (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Jeisys Medical, Inc.?
FDA lists 15 510(k) clearances under the applicant name “Jeisys Medical, Inc.” (first 2008, latest 2024), across 6 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Jeisys Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Jeisys Medical, Inc. is 206 days. Since 2017: 313 days, versus 98 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Jeisys Medical, Inc.?
The most frequent FDA product codes under this applicant name are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 6); GEX (Powered Laser Surgical Instrument, 5); ILY (Lamp, Infrared, Therapeutic Heating, 1).
Next steps
- See all 15 Jeisys Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEI, Jeisys Medical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.