Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd” (first 2016, latest 2024), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 103 days. Since 2017 the median was 90 days, against 90 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 |
|---|---|---|
| 2016 | 1 | 116 |
| 2017 | 1 | 84 |
| 2018 | 0 | — |
| 2019 | 1 | 289 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 57 |
| 2023 | 0 | — |
| 2024 | 2 | 126 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd took a median 90 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 90 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | 4 | 4 |
| NVK | Laser, Dental, Soft Tissue | 1 | 1 |
| PKT | Laser For Disruption Of Adipocyte Cells For Aesthetic Use | 1 | 1 |
Review panels
Most recent Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K243037 | Diode Laser System model Dawn-S | GEX | 2024-12-26 | 90 |
| K232885 | Dawn Diode Laser System | NVK | 2024-02-28 | 163 |
| K222265 | Diosculpt | PKT | 2022-09-23 | 57 |
| K183122 | 810nm Diode Laser System | GEX | 2019-08-25 | 289 |
| K163655 | Sparkling | GEX | 2017-03-17 | 84 |
| K161356 | Matrix LS-40 CO2 Laser System | GEX | 2016-09-09 | 116 |
Recalls
openFDA lists no recalls under a recalling firm named Shanghai Wonderful Opto-Electrics Tech.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.
- Shanghai United Imaging Healthcare Co., Ltd. (85 510(k)s)
- Shanghai AnQing Medical Instrument Co., Ltd. (14 510(k)s)
- Shanghai Antares Industries, Inc. (14 510(k)s)
- Shanghai Apolo Medical Technology Co., Ltd. (14 510(k)s)
- Shanghai Palomar Mountain Industries, Inc. (12 510(k)s)
- Shanghai Sanyou Medical Co, Ltd. (9 510(k)s)
- Shanghai Chenguang Medical Technologies Co, Ltd. (8 510(k)s)
- Shanghai Motex Healthcare Co., Ltd. (8 510(k)s)
- Shanghai Poseidon Plastic Products Co., Ltd. (8 510(k)s)
- Shanghai Champion Plastic Products Co., Ltd. (6 510(k)s)
- Shanghai PT Plastics Enterprise Company, Ltd. (6 510(k)s)
- Shanghai SeeGen Photoelectric Technology Co., Ltd. (6 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd?
FDA lists 6 510(k) clearances under the applicant name “Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd” (first 2016, latest 2024), across 3 product codes in 2 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 Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd?
The median time from FDA receipt to decision across 510(k)s cleared under the name Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd is 103 days. Since 2017: 90 days, versus 90 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 4); NVK (Laser, Dental, Soft Tissue, 1); PKT (Laser For Disruption Of Adipocyte Cells For Aesthetic Use, 1).
Next steps
- See all 6 Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd clearances with predicates and recalls
- Run predicate analysis for product code GEX, Shanghai Wonderful Opto-Electrics Tech.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.