SHENZHEN GSD TECH CO., LTD

FDA Device Registration & Listing · Shenzhen Guangdong, CN · Registration 3006580954

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
3006580954
FEI Number
3006580954
Entity Name
SHENZHEN GSD TECH CO., LTD
City/State/Country
Shenzhen Guangdong, CN
Establishment Address
Building A, JUNSD Hi-Tech Park, Watch & Clock Base, Guangming District, Shenzhen Guangdong 518106, CN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Shenzhen GSD Tech Co., Ltd (Owner Number: 10031346)
Owner / Operator Contact Address
703 Building A, Futian TianAn Hi-Tech Venture Park, Shenzhen, CN-GD 518040, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K191518
PMA Number
N/A

All Registered Proprietary Names

INTENSE PULSED LIGHT SYSTEM GP666C GSD INTENSE PULSED LIGHT SYSTEM GP666C4 DIODE LASER SYSTEM GP900Q6 DIODE LASER HAIR REMOVAL SYSTEM GP900A DIODE LASER HAIR REMOVAL SYSTEM GP900Q 308nm Excimer UV-Light Skin Therapy System GP908B 308nm Excimer UV-Light Skin Therapy System GP908D Diode Laser System GP900A8 Diode Laser System GP900Q8 GP900F CO2 Laser System

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 2010-01-19
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2015-04-23
FTC Light, Ultraviolet, Dermatological General, Plastic Surgery Class 2 878.4630 2020-12-22
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2022-01-04
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2019-11-13

Official Correspondent

No official correspondent registered.

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

Shenzhen GSD Tech 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, 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 3006580954. Last updated year: 2026. Please use registration number 3006580954 when referencing this establishment in official correspondence.
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