SANHE MEDITECH CO., LTD

FDA Device Registration & Listing · Sanhe Hebei, CN · Registration 3027851853

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3027851853
FEI Number
3027851853
Entity Name
SANHE MEDITECH CO., LTD
City/State/Country
Sanhe Hebei, CN
Establishment Address
Unit 3, Building 15, Zhongnan High Tech, No.4 Liushan Street, Yanjiao, Sanhe Hebei 065201, CN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Sanhe Meditech Co., Ltd (Owner Number: 10088569)
Owner / Operator Contact Address
Unit 3, Building 15, Zhongnan High Tech, No.4 Liushan Street, Yanjiao, Sanhe, CN-HE 065201, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K260375
PMA Number
N/A

All Registered Proprietary Names

Diode Laser Hair Removal Machine: GLD21, GLD25, GLD26 Picosecond Laser Machine: GL018, GL019, GL020, GL021, GL022, GL023, GL025, GL026, GL027, GL029 Facial Beauty Machine: GL001, GL002, GL003, GL005, GL006, GL007, GL008, GL009, GL010, GL012, GL015, GLY01, GLY02, GLY03 Diode Laser Hair Removal Machine: GLD05, GLD06, GLD07, GLD08,GLD15, GLD17, GLD18 Plasma Laser Beauty Machine: GL017 Facial Beauty Machine: GLC01, GLC02, GLC03, GLC05, GLC16, GLQ01, GLQ02, GLQ03, GLP03 Air Cooling Machine : GLD12 Picosecond Laser Machine: GL031, GL032, GL035, GL040 CO2 Laser Machine: GL063,GL070, GL080, GL090 CO2 Laser System:GL060, GL062, GL065, GL066, GL067, GL068 Nd YAG Laser Therapy Systems:GL022,GL028,GL030,GL036,GL037, GL038,GL039

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NXF Gas, Laser Generating General, Plastic Surgery Class 1 878.4810 2023-08-17
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2026-04-09
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2026-04-09

Official Correspondent

Xiaoxia Song

US Agent Details

Alex Gary Business: BTS US Inc Email: us@hibts.com Phone: (844) 9823583

Related Public Records

Same Entity

Sanhe Meditech 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, PA***SLT Fiber Delivery System***Sterile***Non-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 3027851853. Last updated year: 2026. Please use registration number 3027851853 when referencing this establishment in official correspondence.
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