Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3023281259

FEI Number

3023281259

Entity Name

SHENZHEN FANSIZHE SCIENCE AND TECHNOLOGY CO., LTD.

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

2nd, 3rd And 4th floors, No.11, Henggangxia Industrial Zone, Xiangshan Community, Xinqiao Street, Bao'an District, Shenzhen Guangdong 518125, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Shenzhen Fansizhe Science And Technology Co., Ltd. (Owner Number: 10085107)

Owner / Operator Contact Address

2nd, 3rd And 4th Floors, No.11, Henggangxia Industrial Zone, Xiangshan Community, Xinqiao Street, Bao'an District, Shenzhen, CN-GD 518125, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K212881

PMA Number

N/A

All Registered Proprietary Names

Intense Pulsed Light (IPL) System (Models: T505KQ, T505KH, T505KF, SL-B505WM) Intense Pulsed Light (IPL) System (Models: T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH) Intense Pulsed Light (IPL) System, Model: T013C, T015C, T015K, T015A Intense Pulsed Light (IPL) System, Model:T021A,T001A,T001B,T001M,T001N,T011C,T016K Intense Pulsed Light (IPL) System, Model:T033KW Intense Pulsed Light (IPL) System, Model:T002AW,T002BW Intense Pulsed Light (IPL) System, Model:T023K,T023A,T023B,T023C,T023D,T023E,T021K Intense Pulsed Light (IPL) System, Model:T033MW Intense Pulsed Light (IPL) System, Model: T053K, T055K, T056K, T026K, T035K Intense Pulsed Light (IPL) System, Model: T012C Intense Pulsed Light (IPL) System, Model: T003AW, T010AW Intense Pulsed Light (IPL) System, Model: T050AW

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OHT	Light Based Over-The-Counter Hair Removal	General, Plastic Surgery	Class 2	878.4810	2025-12-30
OHT	Light Based Over-The-Counter Hair Removal	General, Plastic Surgery	Class 2	878.4810	2022-07-03
ONF	Powered Light Based Non-Laser Surgical Instrument With Thermal Effect	General, Plastic Surgery	Class 2	878.4810	2022-07-03
OHT	Light Based Over-The-Counter Hair Removal	General, Plastic Surgery	Class 2	878.4810	2023-04-10
ONF	Powered Light Based Non-Laser Surgical Instrument With Thermal Effect	General, Plastic Surgery	Class 2	878.4810	2022-05-05
OHT	Light Based Over-The-Counter Hair Removal	General, Plastic Surgery	Class 2	878.4810	2022-05-05

Official Correspondent

EnDang Cheng

US Agent Details

Mike Ryan Business: Simply Shipped, LLC Email: simplyshipped.agent@gmail.com Phone: (262) 4143264

Related Public Records

Same Entity

Shenzhen Fansizhe Science And 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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3023281259. Last updated year: 2026. Please use registration number 3023281259 when referencing this establishment in official correspondence.