Data / Medical devices / China / Miley Technology (hebei) Co., Ltd
Miley Technology (hebei) Co., Ltd: FDA-registered device maker in Handan Hebei, China, 2 510(k) clearances
Miley Technology (hebei) Co., Ltd is registered with the FDA (registration 3027605738) in Handan Hebei, China. It lists 5 device types. The FDA files 2 510(k) clearances under its listings, the newest dated September 15, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3027605738
- Address
- Building 3,High Tech Industrical Zone,South of Xinneng Street, Economic Development Zone, Guantao County, Handan Hebei, China, 057750
- Owner or operator
- Miley Technology (Hebei) Co., LTD (10088284)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- June 24, 2023
- Registered through
- 2026
- Brand names listed
- Baby Nasal Aspirator model BX001.BX002.BX003.BX004.BX005, IPL Hair Removal Device MLY-T069, IPL Hair Removal Device model MLY-M011.MLY-M012.MLY-M013.MLY-M015.MLY-T001.MLY-T002, Oral Irrigator model MLY-F001.MLY-F002.MLY-F003.MLY-F004.MLY-F005, Scraping Instrument model GS01.GS02.GS03
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bottle, Collection, Vacuum | KDQ | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Light Based Over-The-Counter Hair Removal | OHT | 2 | Manufacturer | accessdata.fda.gov |
| Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | ONF | 2 | Manufacturer | accessdata.fda.gov |
| Scrapper, Skin Specimen | LXK | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Unit, Oral Irrigation | EFS | 1 | Contract manufacturer, 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 |
|---|---|---|---|---|---|---|
| September 15, 2025 | K251914 | IPL Hair Removal Device (MLY-M011); IPL Hair Removal Device (MLY-M012); IPL Hair Removal Device (MLY-M013); IPL Hair Removal Device (MLY-M015); IPL Hair Removal Device (MLY-T001); IPL Hair Removal Device (MLY-T002) | OHT | Substantially Equivalent | Miley Technology (Hebei) Co., Ltd. | accessdata.fda.gov |
| June 15, 2023 | K230473 | IPL Hair Removal Device Models: MLY-T069 | OHT | Substantially Equivalent | Miley Technology (Hebei) 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 Light Based Over-The-Counter Hair Removal
- All makers of Unit, Oral Irrigation
- All makers of Scrapper, Skin Specimen
- All makers of Bottle, Collection, Vacuum
Updated September 15, 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.