Endymed Medical, Ltd.: FDA clearances and approvals
Endymed Medical, Ltd. has 7 FDA 510(k) clearances (first 2011, latest 2025), plus 1 De Novo decision, across 6 product codes in 2 review panels. Median 510(k) review time: 231 days. Since 2017 its median was 231 days, against 102 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 77 |
| 2013 | 0 | — |
| 2014 | 1 | 379 |
| 2015 | 0 | — |
| 2016 | 1 | 95 |
| 2017 | 1 | 231 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 63 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 257 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Endymed Medical, Ltd.'s cleared 510(k)s took a median 231 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 102 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OUH | Skin Resurfacing Rf Applicator | 3 | 3 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
| GEX | Powered Laser Surgical Instrument | 1 | 1 |
| GYB | Media, Electroconductive | 1 | 1 |
| PAY | Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction | 1 | 0 |
| PBX | Massager, Vacuum, Radio Frequency Induced Heat | 1 | 1 |
Review panels
Most recent Endymed Medical, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K242996 | EndyMed PRO MAX | GEI | 2025-06-10 | 257 |
| K222369 | PURE Laser | GEX | 2022-10-07 | 63 |
| K161715 | EndyGel | GYB | 2017-02-07 | 231 |
| K161199 | EndyMed Contour Handpiece | PBX | 2016-08-01 | 95 |
| K130501 | INTENSIF | OUH | 2014-03-13 | 379 |
| K120513 | GLOW BY ENDYMED | OUH | 2012-05-08 | 77 |
| K101510 | FRACTIONAL SKIN RESURFACING (FSR) APPLICATOR | OUH | 2011-02-17 | 261 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN150005 | De Novo | Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction | 2015-12-18 |
Recalls
openFDA lists no recalls under a recalling firm named Endymed Medical, Ltd..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Endymed Medical, Ltd. have?
Endymed Medical, Ltd. has 7 FDA 510(k) clearances (first 2011, latest 2025), plus 1 De Novo decision, across 6 product codes in 2 review panels.
How long does FDA take to clear Endymed Medical, Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Endymed Medical, Ltd.'s cleared 510(k)s is 231 days. Since 2017: 231 days, versus 102 days for all cleared 510(k)s in the same product codes.
What devices does Endymed Medical, Ltd. make?
Its most frequent FDA product codes are OUH (Skin Resurfacing Rf Applicator, 3); GEI (Electrosurgical, Cutting & Coagulation & Accessories, 1); GEX (Powered Laser Surgical Instrument, 1).
Has Endymed Medical, Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Endymed Medical, Ltd. Related entities may recall under other names.
Next steps
- See all 7 Endymed Medical, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code OUH, Endymed Medical, Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.