Esc Medical Systems , Ltd.: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Esc Medical Systems , Ltd.” (first 1996, latest 2000), across 1 product code in 1 review panel. Median 510(k) review time under this name: 144 days. 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 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | 13 | 13 |
Review panels
Most recent Esc Medical Systems , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K994014 | ESC INTENSE PULSED LIGHT SYSTEMS: EPILIGHT AND MULTILIGHT | GEX | 2000-02-24 | 90 |
| K991935 | EPILIGHT HAIR REMOVAL SYSTEM, PHOTODERM HR SYSTEM | GEX | 2000-01-27 | 232 |
| K991628 | MODIFIED LX-20 CO2 LASER SYSTEM FAMILY, LX-20SA | GEX | 1999-08-09 | 90 |
| K982119 | DIODE LASER | GEX | 1999-02-04 | 233 |
| K982827 | DERMA K ER:YAG/CO2 LASER | GEX | 1998-09-14 | 34 |
| K974536 | PHOTODERM HR SYSTEM | GEX | 1998-05-20 | 169 |
| K980537 | ND: YAG ACCESSORY FOR PHOTODERM SYSTEM | GEX | 1998-04-15 | 63 |
| K972872 | DERMA K LASER SYSTEM | GEX | 1997-10-28 | 85 |
| K972028 | DERMASCAN SURGICAL LASER SCANNER | GEX | 1997-10-24 | 144 |
| K963249 | EPILIGHT HAIR REMOVAL SYSTEM | GEX | 1997-07-07 | 322 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Esc Medical Systems , Ltd..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Esc Medical Systems , Ltd.?
FDA lists 13 510(k) clearances under the applicant name “Esc Medical Systems , Ltd.” (first 1996, latest 2000), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Esc Medical Systems , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Esc Medical Systems , Ltd. is 144 days.
Which FDA product codes appear under Esc Medical Systems , Ltd.?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 13).
Next steps
- See all 13 Esc Medical Systems , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code GEX, Esc Medical Systems , Ltd.'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.