Shandong Moonlight Electronics Tech Co., Ltd.
Registered establishment in Weifang, Shandong, China. 11 device types, 1 clearance.
Shandong Moonlight Electronics Tech Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Marker, Skin, Device, Rebreathing and 9 other device types. Its earliest product listing with the FDA dates from 2023.
Registration
| Registered name | Shandong Moonlight Electronics Tech Co.,Ltd. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3027605507 |
| FEI number | 3027605507 |
| Establishment type | Manufacturer, Exporter |
Location
| City | Weifang |
|---|---|
| Province | Shandong |
| Address | Huayi Bldg, northwest corner of the intersection of Xinhua Road and Lechuan Street, Economic Development Zone |
| Postal code | 261000 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Ablation System, High Intensity Focus Ultrasound (Hifu), Soft Tissue | Class N | High Intensity Focus Ultrasound (HIFU) System | 2023 | 4 |
| Brush, Dermabrasion, Powered | Class 1 | Aqua Facial Hydrogen Oxygen Bubble System | 2023 | 65 |
| Dermal Cooling Pack/Vacuum/Massager | Class 2 | Cryolipolysis machine | 2025 | 3 |
| Device, Rebreathing | Class 1 | hydrogen generator; inflatable chamber; oxygen chamber; Oxygen Generator | 2026 | 13 |
| Device, Skin Potential Measurement | Class 2 | Skin Analyzer System | 2023 | 6 |
| Gas, Laser Generating | Class 1 | CO2 Fractional Laser System | 2023 | 17 |
| Generator, Oxygen, Portable | Class 2 | Oxygen concentrator | 2026 | 22 |
| Lamp, Infrared, Therapeutic Heating | Class 2 | Red Light Bed; Red light Mask; Red light Pad; Red Light Panel, Therapy Lamp, Red Light Therapy | 2024 | 235 |
| Marker, Skin | Class 1 | Hyperbaric Oxygen Chamber | 2026 | 55 |
| Powered Laser Surgical Instrument | Class 2 | Medical Diode Laser Hair Removal System | 2025 | 92 |
| Stimulator, Muscle, Powered, For Muscle Conditioning | Class 2 | Electromagnetic Stimulator Device | 2025 | 66 |
Clearances
1 clearance names Shandong Moonlight Electronics Tech Co., Ltd. as applicant. 3 are held by other companies 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 |
|---|---|---|---|---|
| K250431 | 2025-05-12 | GEX | Traditional | This company |
| K222920 | 2023-07-20 | CAW | Traditional | Zhengzhou Olive Electronic Technology Co., Ltd. |
| K231318 | 2023-07-07 | NGX | Traditional | Beijing Adss Development Co., Ltd. |
| K172144 | 2017-11-01 | OOK | Traditional | Zeltiq Aesthetics Inc. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2007 |
|---|---|
| Main products | Diode laser hair removal, Picosecond laser, CO2 laser, RF slimming devices |
| Certifications | FDA, CE, ISO13485, MDR, TUV, ROHS |
| Export markets | 105+ countries |
| 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.