Shandong Huamei Technology Co., Ltd.
Manufacturer and brand owner in Weifang, Shandong, China. 5 device types, 4 products catalogued, 2 clearances.
Shandong Huamei Technology Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Brush, Dermabrasion, Powered, Massager, Therapeutic, Electric and 3 other device types. 4 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2019.
Registration
| Registered name | SHANDONG HUAMEI TECHNOLOGY CO.,LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3016170453 |
| FEI number | 3016170453 |
| DUNS | 540583132 |
| Establishment type | Manufacturer |
Location
| City | Weifang |
|---|---|
| Province | Shandong |
| Address | 588,Changning Street,High-tech District |
| Postal code | 261205 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Brush, Dermabrasion, Powered | Class 1 | Microdermabrasion System, Model:JM-100, HydroLUX, Beauty System HM-PL300, Beauty System HM-PL100, Facial Management System,Model:OV-2000 (OxyVERVE), OV-3000 (OxyVERVE), Beauty System HM-PL200, Beauty System HM-PL600 and 1 more | 2020 | 65 |
| Massager, Therapeutic, Electric | Class 1 | Inner ball roller massage machine HM-GL100 HM-GL300 HM-GL600 HM-GL660 HM-GL880 | 2020 | 437 |
| Powered Laser Surgical Instrument | Class 2 | Zemits YAGenix, Nd: YAG Laser Therapy Systems HM-YL900, Photodynamic Therapy (PDT) Equipment HM-PDT 100, Photodynamic Therapy (PDT) Equipment HM-PDT 500, Photodynamic Therapy (PDT) Equipment HM-PDT 900, Photodynamic Therapy (PDT) Equipment HM-PDT 200 and 9 more | 2019 | 92 |
| Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | Class 2 | Photodynamic Therapy (PDT) Equipment HM-PDT 100, Photodynamic Therapy (PDT) Equipment HM-PDT 500, Photodynamic Therapy (PDT) Equipment HM-PDT 900, Photodynamic Therapy (PDT) Equipment HM-PDT 200, Zemits LumaGenix, Intense Pulsed Light Treatment System EROSE-YB6 and 2 more | 2019 | 31 |
| Stimulator, Muscle, Powered, For Muscle Conditioning | Class 2 | EMS Sculpt Machine(HM-EMS900) | 2025 | 66 |
Own-Brand Listings
Clearances
2 clearances name Shandong Huamei Technology Co., Ltd. as applicant. 5 are held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K232982 | 2024-11-25 | NGX | Traditional | This company |
| K162659 | 2017-06-16 | GEX | Traditional | This company |
| K230816 | 2023-04-21 | ONF | Special | Shangdong Huamei Technology Co., Ltd. |
| K202758 | 2020-11-16 | GEX | Traditional | Shangdong Huamei Technology Co., Ltd. |
| K200751 | 2020-05-21 | GEX | Traditional | Shangdong Huamei Technology Co., Ltd. |
| K192521 | 2019-12-06 | ONF | Traditional | Shangdong Huamei Technology Co., Ltd. |
| K192528 | 2019-12-03 | GEX | Traditional | Shangdong Huamei Technology Co., Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2004 |
|---|---|
| Main products | Diode laser systems, CO2 fractional lasers, Picosecond lasers, HIFU machines, IPL/OPT machines |
| Certifications | TUV CE, FDA, ISO13485, ROHS, MDSAP, MHRA, CE |
| Export markets | Worldwide |
| OEM and ODM | Offered |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.