Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3030543531

FEI Number

3030543531

Entity Name

HEBEI NEWANGIE TECHNOLOGY CO., LTD

City/State/Country

Shijiazhuang Hebei, CN

Establishment Address

Room 402, Building A-5, Guoxietang Industrial Park, No. 509 TaihangSouth Street, Hi-Tech Zone, Shijiazhuang Hebei 050035, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Hebei Newangie Technology Co., Ltd (Owner Number: 10089994)

Owner / Operator Contact Address

Room 402, Building A-5, Guoxietang Industrial Park, No. 509 TaihangSouth Street, Hi-Tech Zone, Shijiazhuang, CN-HE 050035, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Diode laser device (BM091) Picosecond laser device (BMPS4) Roller massage lymphatic drainage device-M9+6s Roller massage lymphatic drainage device-M9+9S Roller massage lymphatic drainage device-M9+13S Roller massage lymphatic drainage device-M15 Roller massage lymphatic drainage device-RL9 Shock wave therapy devices-SW6 Shock wave therapy devices-SW2 Shock wave therapy devices-SW4 Shock wave therapy devices-SW19 Shock wave therapy devices-SW10-2 Shock wave therapy devices-SW12 Shock wave therapy devices-SW14-2 Shock wave therapy devices-SW14 Shock wave therapy devices-SW11 Shock wave therapy devices-SW15 Roller massage lymphatic drainage device-RL5 Roller massage lymphatic drainage device-M9+8S Roller massage lymphatic drainage device-RL8 Roller massage lymphatic drainage device-RL1 Roller massage lymphatic drainage device-M9+7s Roller massage lymphatic drainage device-RL7 Roller massage lymphatic drainage device-RL2 Shock wave therapy devices-SW13 Shock wave therapy devices-SW1 Roller massage lymphatic drainage device-RL10 Roller massage lymphatic drainage device-M9+10S Roller massage lymphatic drainage device-RL4 Shock wave therapy devices-SW20 Roller massage lymphatic drainage device-RL6 Shock wave therapy devices-SW9 Roller massage lymphatic drainage device-M9+12S Shock wave therapy devices-SW14-1 Roller massage lymphatic drainage device-M9+14S Shock wave therapy devices-SW8 Shock wave therapy devices-SW10-3 Shock wave therapy devices-SW3 Shock wave therapy devices-SW14-3 Roller massage lymphatic drainage device-RL3 Roller massage lymphatic drainage device-M9+11S Shock wave therapy devices-SW18 Shock wave therapy devices-SW17 Shock wave therapy devices-SW10-1 Shock wave therapy devices-SW5 Shock wave therapy devices-SW10 Roller massage lymphatic drainage device-M9+15S Shock wave therapy devices-SW16

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2025-08-11
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2025-12-17
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2024-01-30

Official Correspondent

Zhaoyu Ning

US Agent Details

Xu Wen Email: infor@believe-med.com Phone: (443) 8968583

Related Public Records

Same Entity

Hebei Newangie Technology 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
K083258	Dornier Medtech America, Inc.	MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE	2009-01-30
K201111	Candela Corporation	GentleMax Pro Plus	2020-05-26
K202758	Shangdong Huamei Technology Co., Ltd.	Nd: YAG Laser Therapy Systems HM-YL900	2020-11-16
K904068	Luxar Corp.	LUXAR MODEL LX-20 CO2 LASER	1991-04-15
K142225	CAO Group, Inc.	Pilot Elite Diode Laser	2014-09-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0005-2014	PhotoMedex, Inc.	2	The product is labeled in part "*Surgical Laser Technologies, Inc. Montgomeryville, PASLT Fiber Delivery SystemSterileNon-Pyrogenic**. The product is packaged in a flexible pouch and includes the following laser surgery accessories - SLT-SSRH 8, Catalog/Product Number 0041-3082; SLT-SSRH 11, Catalog/Product Number 0041-3112; SLT-SSRH 4-SMA, Catalog/Product Number 0042-0075; SLT-SSRH 5-SMA, Catalog/Product Number 0042-0076; SLT-SSRH 6-SMA, Catalog/Product Number 0042-0077; SLT-SSRH 7-SMA, Catalog/Product Number 0042-0078; SLT-SSRH 8-SMA, Catalog/Product Number 0042-0079; SLT-SSRH 9-SMA, Catalog/Product Number 0041-4931; and SLT-SSRH 10-SMA, Catalog/Product Number 0042-0081. Indicated for the incision, excision, coagulations, and vaporization of soft tissue.
Z-0025-2018	Medtronic Navigation, Inc.	2	VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559 Visualase Cooled Laser Applicator System 3mm Tip; Part Number: 9735560 Visualase Cooled Laser Applicator System 10mm Tip; Part Number: 9735561 Visualase Cooled Laser Applicator System 15mm Tip
Z-0028-2007	Lumenis Inc.	2	Lumenis brand DuoTome SideLite 550 Micron Delivery System; laser systems for ablating soft tissue. Catalog Number: 0641-800-01; Manufactured by Lumenis, Inc., 2400 Condensa Street, Santa Clara, CA

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030543531. Last updated year: 2026. Please use registration number 3030543531 when referencing this establishment in official correspondence.