Wuhan Lotuxs Technology Co., Ltd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Wuhan Lotuxs Technology Co., Ltd.” (first 2015, latest 2024), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 134 days. Since 2017 the median was 116 days, against 88 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 |
|---|---|---|
| 2015 | 1 | 274 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 1 | 86 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 2 | 116 |
| 2024 | 1 | 215 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Wuhan Lotuxs Technology Co., Ltd. took a median 116 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 88 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | 2 | 2 |
| OHT | Light Based Over-The-Counter Hair Removal | 2 | 2 |
| PKT | Laser For Disruption Of Adipocyte Cells For Aesthetic Use | 1 | 1 |
Review panels
Most recent Wuhan Lotuxs Technology Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K231910 | DermRays Revive | GEX | 2024-01-30 | 215 |
| K232117 | Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064) | GEX | 2023-11-28 | 134 |
| K230090 | Diode Laser Hair Removal | OHT | 2023-04-19 | 97 |
| K191068 | Powersculp laser lipolysis system | PKT | 2019-07-17 | 86 |
| K142845 | SILKPRO laser hair removal system | OHT | 2015-07-01 | 274 |
Recalls
openFDA lists no recalls under a recalling firm named Wuhan Lotuxs Technology Co., 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.
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.
- Wuhan Pioon Technology Co., Ltd. (8 510(k)s)
- Wuhan Zonsen Medical Products Co., Ltd. (6 510(k)s)
- Wuhan Dymex Healthcare Co., Ltd. (4 510(k)s)
- Wuhan Dimed Laser Technology Co., Ltd. (2 510(k)s)
- Wuhan Gigaa Optronics Technology Co., Ltd. (2 510(k)s)
- Wuhan Greentek Pty , Ltd. (2 510(k)s)
- Wuhan United Imaging Healthcare Co.,Ltd (2 510(k)s)
- Wuhan Guangdun Technology Co.,Ltd.. (1 510(k)s)
- Wuhan Huashida Protective Products Co., Ltd. (1 510(k)s)
- Wuhan Huchuang Union Technology Co., Ltd. (1 510(k)s)
- Wuhan Huirui Technology Co., Ltd. (1 510(k)s)
- Wuhan Landing Medical Hi-Tech, Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Wuhan Lotuxs Technology Co., Ltd.?
FDA lists 5 510(k) clearances under the applicant name “Wuhan Lotuxs Technology Co., Ltd.” (first 2015, latest 2024), across 3 product codes 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 Wuhan Lotuxs Technology Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Wuhan Lotuxs Technology Co., Ltd. is 134 days. Since 2017: 116 days, versus 88 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Wuhan Lotuxs Technology Co., Ltd.?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 2); OHT (Light Based Over-The-Counter Hair Removal, 2); PKT (Laser For Disruption Of Adipocyte Cells For Aesthetic Use, 1).
Next steps
- See all 5 Wuhan Lotuxs Technology Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code GEX, Wuhan Lotuxs Technology Co., 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.