Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3040278125

FEI Number

3040278125

Entity Name

FOSHAN ZIKE TECHNOLOGY CO., LTD.

City/State/Country

Foshan Guangdong, CN

Establishment Address

Room 503, 5th Floor, Workshop A, No. 5, Xiaheng 1st Road, Shayong, Lishui Town, Nanhai District,, Foshan Guangdong 528244, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Foshan Zike Technology Co., Ltd. (Owner Number: 10094939)

Owner / Operator Contact Address

Room 503, 5th Floor, Workshop A, No. 5, Xiaheng 1st Road, Shayong, Lishui Town, Nanhai District,, Foshan, CN-GD 528244, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ZK-RF12,ZK-RF13,ZK-RF14,ZK-RF15,ZK-RF16,ZK-RF17,ZK-RF18,ZK-RF19,ZK-RF20 Rf Microneedling Machine:ZK-RF01,ZK-RF02,ZK-RF03,ZK-RF04,ZK-RF05,ZK-RF06,ZK-RF07,ZK-RF08,ZK-RF09,ZK-RF10,ZK-RF11, Spa capsule:ZK-SC01,ZK-SC02,ZK-SC03,ZK-SC04,ZK-SC05, ZK-SC06,ZK-SC07,ZK-SC08,ZK-SC09,ZK-SC10,ZK-SC11,ZK-SC12,ZK-SC13,ZK-SC14,ZK-SC15,ZK-SC16,ZK-SC17,ZK-SC18,ZK-SC19,ZK-SC20 Laser slimming machine:ZK-S01,ZK-S02,ZK-S03,ZK-S04,ZK-S05,ZK-S06,ZK-S07,ZK-S08,ZK-S09,ZK-S10,ZK-S11,ZK-S12,ZK-S13, ZK-S14,ZK-S16,ZK-S17,ZK-S18,ZK-S19,ZK-S20 Facial Spa Oxygen Hydro Facial Beauty System:ZK-F01,ZK-F02,ZK-F03,ZK-F04,ZK-F05,ZK-F06, Body analyzer machine:ZK-BA01,ZK-BA02,ZK-BA03,ZK-BA04,ZK-BA05,ZK-BA06,ZK-BA07,ZK-BA08,ZK-BA09, Skin analyzer machine:ZK-SA01,ZK-SA02,ZK-SA03,ZK-SA04,ZK-SA05,ZK-SA06,ZK-SA07,ZK-SA08,ZK-SA09, ZK-H07,ZK-H08,ZK-H09,ZK-H10,ZK-H11,ZK-H12,ZK-H13,ZK-H14,ZK-H15,ZK-H16,ZK-H17,ZK-H18,ZK-H19,ZK-H20 ZK-F07,ZK-F08,ZK-F09,ZK-F10,ZK-F11,ZK-F12,ZK-F13,ZK-F14,ZK-F15,ZK-F16,ZK-F17,ZK-F18,ZK-F19,ZK-F20 ZK-BA10,ZK-BA11,ZK-BA12,ZK-BA13,ZK-BA14,ZK-BA15,ZK-BA16,ZK-BA17,ZK-BA18,ZK-BA19,ZK-BA20, Hyperbaric Oxygen Chamber:ZK-H01,ZK-H02,ZK-H03,ZK-H04,ZK-H05,ZK-H06, ZK-SA10,ZK-SA11,ZK-SA12,ZK-SA13,ZK-SA14,ZK-SA15,ZK-SA16,ZK-SA17,ZK-SA18,ZK-SA19,ZK-SA20 Air pressure suit:ZK-A01,ZK-A02,ZK-A03,ZK-A04,ZK-A05,ZK-A06,ZK-A07,ZK-A08,ZK-A09,ZK-A10,ZK-A11,ZK-A12,ZK-A13, ZK-A14,ZK-A15,ZK-A16,ZK-A17,ZK-A18,ZK-A19,ZK-A20 3D digital nail printer machine:ZK-P01,ZK-P02,ZK-P03,ZK-P04,ZK-P05,ZK-P06, ZK-P07,ZK-P08,ZK-P09,ZK-P10 Diode Laser Hair Removal System:ZK-D01,ZK-D02,ZK-D03,ZK-D04,ZK-D05,ZK-D06,ZK-D07,ZK-D08,ZK-D09,ZK-D10,ZK-D11,ZK-D12, ZK-D13,ZK-D14,ZK-D15,ZK-D16,ZK-D17,ZK-D18,ZK-D19,ZK-D20 ZK-F08,ZK-F09,ZK-F10,ZK-F11,ZK-F12,ZK-F13,ZK-F14,ZK-F15,ZK-F15,ZK-F16,ZK-F17,ZK-F18,ZK-F19,ZK-F20 ZK-P08,ZK-P09,ZK-P10,ZK-P11,ZK-P12,ZK-P13,ZK-P14,ZK-P15,ZK-P16,ZK-P17,ZK-P18,ZK-P19,ZK-P20 Multi-functional 980 1470 Diode Laser Machine:ZK-L01,ZK-L02,ZK-L03,ZK-L04,ZK-L05,ZK-L06,ZK-L07, Picosecond Laser Machine:ZK-P01,ZK-P02,ZK-P03,ZK-P04,ZK-P05,ZK-P06,ZK-P07, ZK-L08,ZK-L09,ZK-L10,ZK-L10,ZK-L11,ZK-L12,ZK-L13,ZK-L14,ZK-L15,ZK-L16,ZK-L17,ZK-L18,ZK-L19,ZK-L20 Fractional CO2 Laser System Machine:ZK-F01,ZK-F02,ZK-F03,ZK-F04,ZK-F05,ZK-F06,ZK-F07,

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GDF	Guide, Needle, Surgical	General, Plastic Surgery	Class 1	878.4800	2026-01-07
IRT	Pad, Heating, Powered	Physical Medicine	Class 2	890.5740	2026-01-07
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2026-01-07
FZZ	Marker, Skin	General, Plastic Surgery	Class 1	878.4660	2026-01-07
ECB	Unit, Syringe, Air And/Or Water	Dental	Class 1	872.4565	2026-01-07
JQP	Calculator/Data Processing Module, For Clinical Use	Clinical Chemistry	Class 1	862.2100	2026-01-07
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2026-01-07
NXF	Gas, Laser Generating	General, Plastic Surgery	Class 1	878.4810	2026-01-07

Official Correspondent

Li Peng

US Agent Details

Yuan Dan Email: service20210328@hotmail.com Phone: (805) 3513025

Related Public Records

Same Entity

Foshan Zike 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
K881862	Thermo Body Wrap Systems, Inc.	THERMO-BODY-WRAP SYSTEM	1988-10-13
K781173	Instrumentation Laboratory CO	COMPUTER INTERFACE IL 814	1978-09-14
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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-04	Misys Healthcare Systems	1	Calculator/Data Processing Module for Clinical Use
Z-0026-2025	Becton Dickinson & Co.	1	BD Synapsys Informatics Solution with software versions: 4.20, 4.30, 5.10, 5.20 and 5.30- IVD standalone laboratory software solution providing data management and workflow management functionality across locations where clinical diagnostic activities take place. Catalog Number: 444150
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 3040278125. Last updated year: 2026. Please use registration number 3040278125 when referencing this establishment in official correspondence.