Ellex Medical Pty, Ltd.: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Ellex Medical Pty, Ltd.” (first 1997, latest 2022), across 3 product codes in 3 review panels. Median 510(k) review time under this name: 88 days. Since 2017 the median was 86 days, against 91 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 | 1 | 341 |
| 2014 | 0 | — |
| 2015 | 1 | 321 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 1 | 15 |
| 2020 | 0 | — |
| 2021 | 1 | 119 |
| 2022 | 1 | 86 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Ellex Medical Pty, Ltd. took a median 86 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 91 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HQF | Laser, Ophthalmic | 8 | 8 |
| GEX | Powered Laser Surgical Instrument | 4 | 4 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 1 | 1 |
Review panels
- Ophthalmic (8)
- General and Plastic Surgery (4)
- Radiology (1)
Most recent Ellex Medical Pty, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K222395 | Tango Neo, Tango Reflex Neo, Ultra Q Reflex Neo | HQF | 2022-11-02 | 86 |
| K212630 | Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, Solo | HQF | 2021-12-16 | 119 |
| K190786 | Eye Prime | IYO | 2019-04-11 | 15 |
| K142398 | Integre Pro Scan Green, Integre Pro Scan Yellow, Integre Pro Scan Red-Green, Integre Pro Scan Red-Yellow | HQF | 2015-07-14 | 321 |
| K122202 | ELLEX 2RT | HQF | 2013-07-01 | 341 |
| K081565 | INTEGRE PRO, MODEL L2RY | HQF | 2008-07-02 | 28 |
| K080423 | INTEGRE, MODEL LP581 | HQF | 2008-03-11 | 25 |
| K052777 | LASEREX DUO FAMILY OF DUAL WAVELENGTH OPHTHALMIC LASERS INCLUDING MODELS INTEGRE DUO LP1RG-S, LP1RG-D | GEX | 2006-03-16 | 164 |
| K041598 | LASEREX, MODEL LP4532 | HQF | 2004-10-06 | 114 |
| K021550 | LUMENIS SELECTA DUET | GEX | 2002-08-09 | 88 |
3 earlier clearances. See the full list in Caduvo.
Recalls
8 product recalls in 3 recall events; 1 initiated in the last five years. Most recent: 2023-03-16.
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.
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.
- Ellex, Inc. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Ellex Medical Pty, Ltd.?
FDA lists 13 510(k) clearances under the applicant name “Ellex Medical Pty, Ltd.” (first 1997, latest 2022), across 3 product codes in 3 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 Ellex Medical Pty, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ellex Medical Pty, Ltd. is 88 days. Since 2017: 86 days, versus 91 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Ellex Medical Pty, Ltd.?
The most frequent FDA product codes under this applicant name are HQF (Laser, Ophthalmic, 8); GEX (Powered Laser Surgical Instrument, 4); IYO (System, Imaging, Pulsed Echo, Ultrasonic, 1).
Next steps
- See all 13 Ellex Medical Pty, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code HQF, Ellex Medical Pty, 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.