Data / Medical devices / China / Shanghai Bele Medical Technology Co.,ltd
Shanghai Bele Medical Technology Co.,ltd: FDA-registered device maker in Shanghai, China, 3 510(k) clearances
Shanghai Bele Medical Technology Co.,ltd is registered with the FDA (registration 3027619554) in Shanghai, China. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated May 20, 2024. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3027619554
- Address
- Room 402, 4F, Building 1, NO.3255 Shengang Road, Songjiang District, Shanghai, China, 201600
- Owner or operator
- SHANGHAI BELE MEDICAL TECHNOLOGY CO.,LTD (10088290)
- Roles
- Manufacturer
- First device listed
- June 25, 2023
- Registered through
- 2026
- Brand names listed
- Diode Laser Body Sculpture Systems(BL-A10), Multi-function Platform Systems(BL-M10), Picosecond ND:YAG laser system(BL-C10)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Laser For Disruption Of Adipocyte Cells For Aesthetic Use | PKT | 2 | Manufacturer | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Manufacturer | accessdata.fda.gov |
| Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | ONF | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 20, 2024 | K240474 | Multi-function Platform Systems (BL-M10) | GEX | Substantially Equivalent | Shanghai Bele Medical Technology Co.,Ltd | accessdata.fda.gov |
| May 16, 2024 | K240386 | Picosecond Nd:YAG Laser Systems (BL-C10) | GEX | Substantially Equivalent | Shanghai Bele Medical Technology Co.,Ltd | accessdata.fda.gov |
| June 22, 2023 | K231131 | Diode Laser Body Sculpture Systems | PKT | Substantially Equivalent | Shanghai Bele Medical Technology Co.,Ltd | accessdata.fda.gov |
Compare with other makers
- All makers of Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
- All makers of Powered Laser Surgical Instrument
- All makers of Laser For Disruption Of Adipocyte Cells For Aesthetic Use
Updated May 20, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.