Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.” (first 2025, latest 2026), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 83 days. Since 2017 the median was 83 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 |
|---|---|---|
| 2025 | 5 | 83 |
| 2026 | 2 | 76 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. took a median 83 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 | 5 | 5 |
| FFK | Lithotriptor, Electro-Hydraulic | 2 | 2 |
Review panels
Most recent Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253951 | Holmium Laser Therapeutic Apparatus (HZ-A); Holmium Laser Therapeutic Apparatus (HZ-B); Holmium Laser Therapeutic Apparatus (HZ-E) | GEX | 2026-03-06 | 86 |
| K253633 | Holmium Laser Therapeutic Apparatus (HZ-40) | GEX | 2026-01-24 | 66 |
| K252787 | Thulium Fiber Laser System (TFL-A); Thulium Fiber Laser System (TFL-B) | GEX | 2025-11-24 | 83 |
| K252771 | Holmium Laser System (Potent HP90); Holmium Laser System (Potent HP100); Holmium Laser System (Potent HP9120); Holmium Laser System (Potent HP140); Holmium Laser System (Potent HP150) | GEX | 2025-11-24 | 83 |
| K253007 | Laser Fiber (PT-OF-A-S); Laser Fiber (PT-OF-B-S); Laser Fiber (PT-OF-C-S); Laser Fiber (PT-OF-D-S); Laser Fiber (PT-OF-E-S); Laser Fiber (PT-OF-F-S) | GEX | 2025-11-20 | 62 |
| K243032 | EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS) | FFK | 2025-03-21 | 175 |
| K242888 | Electrohydraulic Lithotriptor (TCS-B3-II) | FFK | 2025-03-21 | 179 |
Recalls
openFDA lists no recalls under a recalling firm named Guangzhou Potent Medical Equipment Joint-Stock 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.
- Guangzhou Wondfo Biotech Co., Ltd. (43 510(k)s)
- Guangzhou Xinbo Electronic Co., Ltd. (12 510(k)s)
- Guangzhou Red Pine Medical Instrument Co., Ltd. (10 510(k)s)
- Guangzhou Decheng Biotechnology Co., Ltd. (8 510(k)s)
- Guangzhou Berrcom Medical Device Co., Ltd. (6 510(k)s)
- Guangzhou Longest Science & Technology Co., Ltd. (6 510(k)s)
- Guangzhou Heygears IMC., Inc. (4 510(k)s)
- Guangzhou Ajax Medical Equipment Co., Ltd. (3 510(k)s)
- Guangzhou Finecure Medical Equipment Co.,Ltd (3 510(k)s)
- Guangzhou Longest Medical Technology Co., Ltd. (3 510(k)s)
- Guangzhou Sonostar Technologies Co., Ltd. (3 510(k)s)
- Guangzhou Chemicals Import & Export Corp. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.?
FDA lists 7 510(k) clearances under the applicant name “Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.” (first 2025, latest 2026), across 2 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 Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. is 83 days. Since 2017: 83 days, versus 90 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 5); FFK (Lithotriptor, Electro-Hydraulic, 2).
Next steps
- See all 7 Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code GEX, Guangzhou Potent Medical Equipment Joint-Stock 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.