Data / Medical devices / China / Shandong Moonlight Electronics Tech Co.,Ltd.
Shandong Moonlight Electronics Tech Co.,Ltd.: FDA-registered device maker in Weifang Shandong, China, 4 510(k) clearances
Shandong Moonlight Electronics Tech Co.,Ltd. is registered with the FDA (registration 3027605507) in Weifang Shandong, China. It lists 11 device types. The FDA files 4 510(k) clearances under its listings, the newest dated May 12, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3027605507
- Address
- Huayi Bldg, northwest corner of the intersection of Xinhua Road and Lechuan Street, Economic Development Zone, Weifang Shandong, China, 261000
- Owner or operator
- Shandong Moonlight Electronics Tech Co.,Ltd. (10088202)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- June 9, 2023
- Registered through
- 2026
- Brand names listed
- Aqua Facial Hydrogen Oxygen Bubble System, CO2 Fractional Laser System, Cryolipolysis machine, Electromagnetic Stimulator Device, High Intensity Focus Ultrasound (HIFU) System, Hyperbaric Oxygen Chamber, Medical Diode Laser Hair Removal System, Oxygen concentrator and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Ablation System, High Intensity Focus Ultrasound (Hifu), Soft Tissue | PZC | N | Manufacturer | accessdata.fda.gov |
| Brush, Dermabrasion, Powered | GFE | 1 | Manufacturer | accessdata.fda.gov |
| Dermal Cooling Pack/Vacuum/Massager | OOK | 2 | Manufacturer | accessdata.fda.gov |
| Device, Rebreathing | BYW | 1 | Exporter to the US | accessdata.fda.gov |
| Device, Skin Potential Measurement | HCJ | 2 | Manufacturer | accessdata.fda.gov |
| Gas, Laser Generating | NXF | 1 | Manufacturer | accessdata.fda.gov |
| Generator, Oxygen, Portable | CAW | 2 | Exporter to the US | accessdata.fda.gov |
| Lamp, Infrared, Therapeutic Heating | ILY | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Marker, Skin | FZZ | 1 | Manufacturer | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 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 |
|---|---|---|---|---|---|---|
| May 12, 2025 | K250431 | Medical Diode Laser Hair Removal System (MNLT-D1) | GEX | Substantially Equivalent | Shandong Moonlight Electronics Tech Co., Ltd. | accessdata.fda.gov |
| July 20, 2023 | K222920 | Oxygen concentrator | CAW | Substantially Equivalent | Zhengzhou Olive Electronic Technology Co., Ltd. | accessdata.fda.gov |
| July 7, 2023 | K231318 | Electromagnetic Stimulator Device(Model EM Contouring and Tesla Duet) | NGX | Substantially Equivalent | Beijing Adss Development Co., Ltd. | accessdata.fda.gov |
| November 1, 2017 | K172144 | CoolSculpting System | OOK | Substantially Equivalent | Zeltiq Aesthetics | accessdata.fda.gov |
Compare with other makers
- All makers of Stimulator, Muscle, Powered, For Muscle Conditioning
- All makers of Brush, Dermabrasion, Powered
- All makers of Powered Laser Surgical Instrument
- All makers of Generator, Oxygen, Portable
- All makers of Ablation System, High Intensity Focus Ultrasound (Hifu), Soft Tissue
- All makers of Gas, Laser Generating
Updated May 12, 2025. 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.