Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3027619554

FEI Number

3027619554

Entity Name

SHANGHAI BELE MEDICAL TECHNOLOGY CO.,LTD

City/State/Country

Shanghai, CN

Establishment Address

Room 402, 4F, Building 1, NO.3255 Shengang Road, Songjiang District, Shanghai 201600, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SHANGHAI BELE MEDICAL TECHNOLOGY CO.,LTD (Owner Number: 10088290)

Owner / Operator Contact Address

Room 402, 4F, Building 1, NO.3255 Shengang Road, Songjiang District, Shanghai, CN-SH 201600, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K240386

PMA Number

N/A

All Registered Proprietary Names

Multi-function Platform Systems(BL-M10) Picosecond ND:YAG laser system(BL-C10)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ONF	Powered Light Based Non-Laser Surgical Instrument With Thermal Effect	General, Plastic Surgery	Class 2	878.4810	2024-06-01
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2024-06-01
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2024-06-01

Official Correspondent

Jeremy Li

US Agent Details

James St WU Business: Humiss Inc. Email: cc401vip@126.com Phone: (720) 7595888

Related Public Records

Same Entity

SHANGHAI BELE MEDICAL 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
K192521	Shangdong Huamei Technology Co., Ltd.	Intense Pulsed Light Treatment System	2019-12-06
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

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

Similar Registrations

Registration Number	Establishment Name	Location
3033891767	Guangzhou Enzoeys photoelectric Technology Co., Ltd.	Guangzhou Guangdong, CN
3006580954	SHENZHEN GSD TECH CO., LTD	Shenzhen Guangdong, CN
3007085226	Vydence Medical Industria e Comercio Ltda	CEAT - Sao Carlos/SP Sao Paulo, BR
3043047259	BLINK BRIGHT MEDICAL, INC.	Houston, TX, US
3012799115	BEIJING GLOBALIPL DEVELOPMENT CO., LTD.	Beijing, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027619554. Last updated year: 2026. Please use registration number 3027619554 when referencing this establishment in official correspondence.