Zhengzhou PZ Laser Slim Technology Co., Ltd.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Zhengzhou PZ Laser Slim Technology Co., Ltd.” (first 2018, latest 2026), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 98 days. Since 2017 the median was 98 days, against 94 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 |
|---|---|---|
| 2018 | 1 | 68 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 5 | 90 |
| 2026 | 4 | 108 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Zhengzhou PZ Laser Slim Technology Co., Ltd. took a median 98 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 94 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | 8 | 8 |
| NGX | Stimulator, Muscle, Powered, For Muscle Conditioning | 1 | 1 |
| NUV | Massager, Vacuum, Light Induced Heating | 1 | 1 |
Review panels
Most recent Zhengzhou PZ Laser Slim Technology Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261817 | Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02) | GEX | 2026-09-17 | 108 |
| K261589 | 1927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02) | GEX | 2026-09-02 | 112 |
| K261582 | Vacuum Roller RF Slimming Device for Medical Use (PZ-FY66-01, PZ-FY66-02) | NUV | 2026-08-28 | 107 |
| K261821 | 1565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02) | GEX | 2026-08-27 | 87 |
| K252732 | 1927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02) | GEX | 2025-10-23 | 56 |
| K251339 | Medical Diode Laser Hair Removal Device (PZ-606¿, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03, PZ-BDT68-04) | GEX | 2025-07-25 | 86 |
| K250782 | Fractional CO2 Laser Machine | GEX | 2025-06-12 | 90 |
| K250038 | Muscle Stimulator Device (PZ-100) | NGX | 2025-05-19 | 131 |
| K250041 | Medical Picosecond ND: YAG Laser System (PZ-6) | GEX | 2025-05-14 | 126 |
| K180353 | Diode laser hair removal device | GEX | 2018-04-17 | 68 |
Recalls
openFDA lists no recalls under a recalling firm named Zhengzhou PZ Laser Slim 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.
- Zhengzhou Bestview ST Co., Ltd. (2 510(k)s)
- Zhengzhou Huaer Electro Optics Technology Co., Ltd. (1 510(k)s)
- Zhengzhou Olive Electronic Technology Co., Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Zhengzhou PZ Laser Slim Technology Co., Ltd.?
FDA lists 10 510(k) clearances under the applicant name “Zhengzhou PZ Laser Slim Technology Co., Ltd.” (first 2018, latest 2026), 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 Zhengzhou PZ Laser Slim Technology Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Zhengzhou PZ Laser Slim Technology Co., Ltd. is 98 days. Since 2017: 98 days, versus 94 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Zhengzhou PZ Laser Slim Technology Co., Ltd.?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 8); NGX (Stimulator, Muscle, Powered, For Muscle Conditioning, 1); NUV (Massager, Vacuum, Light Induced Heating, 1).
Next steps
- See all 10 Zhengzhou PZ Laser Slim Technology Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code GEX, Zhengzhou PZ Laser Slim 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.