Data / Medical devices / China / Shandong Huamei Technology Co.,ltd.
Shandong Huamei Technology Co.,ltd.: FDA-registered device maker in Weifang Shandong, China, 7 510(k) clearances
Shandong Huamei Technology Co.,ltd. is registered with the FDA (registration 3016170453) in Weifang Shandong, China. It lists 5 device types. The FDA files 7 510(k) clearances under its listings, the newest dated November 25, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016170453
- Address
- 588,Changning Street,High-tech District, Weifang Shandong, China, 261205
- Owner or operator
- Shandong Huamei Technology Co Ltd (10061692)
- Roles
- Manufacturer
- First device listed
- November 10, 2019
- Registered through
- 2026
- Brand names listed
- Beauty System HM-PL100, Beauty System HM-PL200, Beauty System HM-PL300, Beauty System HM-PL600, CO2 Laser Therapy System HM-CL200, Diode Laser Hair Removal System HM-DL100, Diode Laser Hair Removal System HM-DL200, Diode Laser Hair Removal System HM-DL220 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Brush, Dermabrasion, Powered | GFE | 1 | Manufacturer | accessdata.fda.gov |
| Massager, Therapeutic, Electric | ISA | 1 | 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 |
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | 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 |
|---|---|---|---|---|---|---|
| November 25, 2024 | K232982 | EMS Sculpt Machine | NGX | Substantially Equivalent | Shandong Huamei Technology Co., Ltd. | accessdata.fda.gov |
| April 21, 2023 | K230816 | Intense Pulsed Light Treatment System | ONF | Substantially Equivalent | Shangdong Huamei Technology Co., Ltd. | accessdata.fda.gov |
| November 16, 2020 | K202758 | Nd: YAG Laser Therapy Systems HM-YL900 | GEX | Substantially Equivalent | Shangdong Huamei Technology Co., Ltd. | accessdata.fda.gov |
| May 21, 2020 | K200751 | Photodynamic Therapy (PDT) Equipment | GEX | Substantially Equivalent | Shangdong Huamei Technology Co., Ltd. | accessdata.fda.gov |
| December 6, 2019 | K192521 | Intense Pulsed Light Treatment System | ONF | Substantially Equivalent | Shangdong Huamei Technology Co., Ltd. | accessdata.fda.gov |
| December 3, 2019 | K192528 | CO2 Laser Therapy System | GEX | Substantially Equivalent | Shangdong Huamei Technology Co., Ltd. | accessdata.fda.gov |
| June 16, 2017 | K162659 | Diode Laser Hair Removal System | GEX | Substantially Equivalent | Shandong Huamei Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Powered Laser Surgical Instrument
- All makers of Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
- All makers of Brush, Dermabrasion, Powered
- All makers of Stimulator, Muscle, Powered, For Muscle Conditioning
- All makers of Massager, Therapeutic, Electric
Updated November 25, 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.