Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3027605738

FEI Number

3027605738

Entity Name

MILEY TECHNOLOGY (HEBEI) CO., LTD

City/State/Country

Handan Hebei, CN

Establishment Address

Building 3,High Tech Industrical Zone,South of Xinneng Street, Economic Development Zone, Guantao County, Handan Hebei 057750, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Miley Technology (Hebei) Co., LTD (Owner Number: 10088284)

Owner / Operator Contact Address

Building 3,High Tech Industrical Zone,South of Xinneng Street, Economic Development Zone, Guantao County, Handan, CN-HE 057750, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K251914

PMA Number

N/A

All Registered Proprietary Names

Scraping Instrument model GS01.GS02.GS03 IPL Hair Removal Device MLY-T069 Oral Irrigator model MLY-F001.MLY-F002.MLY-F003.MLY-F004.MLY-F005 IPL Hair Removal Device model MLY-M011.MLY-M012.MLY-M013.MLY-M015.MLY-T001.MLY-T002

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LXK	Scrapper, Skin Specimen	General, Plastic Surgery	Class 1	878.4800	2026-01-11
ONF	Powered Light Based Non-Laser Surgical Instrument With Thermal Effect	General, Plastic Surgery	Class 2	878.4810	2023-06-24
OHT	Light Based Over-The-Counter Hair Removal	General, Plastic Surgery	Class 2	878.4810	2023-06-24
EFS	Unit, Oral Irrigation	Dental	Class 1	872.6510	2024-10-30
OHT	Light Based Over-The-Counter Hair Removal	General, Plastic Surgery	Class 2	878.4810	2025-12-24

Official Correspondent

CaiXia Sun

US Agent Details

Anna Sun Business: SUN LUNA STAR LLC Email: usa@medpath.pro Phone: (626) 2005096

Related Public Records

Same Entity

Miley Technology (Hebei) Co., LTD

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K192521	Shangdong Huamei Technology Co., Ltd.	Intense Pulsed Light Treatment System	2019-12-06
K844318	Pro Pulse, Inc.	ORAL IRRIGATION TIP	1984-11-23

Similar Registrations

Registration Number	Establishment Name	Location
3015487912	SHANGHAI REACH MEDICAL INSTRUMENT CO., LTD	Shanghai, CN
3007597038	SURGICON PVT LTD	Sialkot Punjab, PK
9610621	BAUER UND HASELBARTH-CHIRURG GMBH	ELLERAU Schleswig-Holstein, DE
2916714	AESCULAP, INC.	CENTER VALLEY, PA, US
3011096435	SHENZHEN TRENDZ TECHNOLOGY CO.,LTD	Shenzhen Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027605738. Last updated year: 2026. Please use registration number 3027605738 when referencing this establishment in official correspondence.