Depilase Group , Ltd.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Depilase Group , Ltd.” (first 2000, latest 2003), across 1 product code in 1 review panel. Median 510(k) review time under this name: 79 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 | 7 | 7 |
Review panels
Most recent Depilase Group , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K030508 | DEPILASE TRIO LASE LASER SYSTEM | GEX | 2003-05-20 | 90 |
| K030510 | DEPILASE TWIN YAG LASER SYSTEM | GEX | 2003-05-14 | 84 |
| K030506 | DEPILASE YAG LASE PLUS LASER SYSTEM | GEX | 2003-05-09 | 79 |
| K020697 | DEPILASE TWIN YAG LASER SYSTEM | GEX | 2002-04-12 | 39 |
| K020463 | DEPILASE YAG LASE PLUS LASER SYSTEM | GEX | 2002-02-27 | 15 |
| K020412 | DEPILASE TWIN LASE LASER SYSTEM | GEX | 2002-02-22 | 15 |
| K001990 | DEPILASE YAGLASE ND:YAG LASER SYSTEM AND ACCESSORIES | GEX | 2000-10-23 | 116 |
Recalls
openFDA lists no recalls under a recalling firm named Depilase Group , 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 Depilase Group , Ltd.?
FDA lists 7 510(k) clearances under the applicant name “Depilase Group , Ltd.” (first 2000, latest 2003), 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 Depilase Group , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Depilase Group , Ltd. is 79 days.
Which FDA product codes appear under Depilase Group , Ltd.?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 7).
Next steps
- See all 7 Depilase Group , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code GEX, Depilase Group , 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.