Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3026132991

FEI Number

3026132991

Entity Name

Shenzhen IONKA Medical Technology Co., Ltd.

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

Room 601, No. 3, Jiazitang Second Industrial Zone, Jiazitang Community, Fenghuang Street, Guangming District, Shenzhen Guangdong 518132, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Shenzhen IONKA Medical Technology Co., Ltd. (Owner Number: 10086648)

Owner / Operator Contact Address

Room 601, No. 3, Jiazitang Second Industrial Zone, Jiazitang Community, Fenghuang Street, Guangming District, Shenzhen, CN-GD 518132, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K230739

PMA Number

N/A

All Registered Proprietary Names

Hand-held IPL device (IPL Home Use Hair Removal Device), Model: FZ-608, FZ-608G, FZ-100, FZ-200

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	2023-05-29

Official Correspondent

Dongfa Chen

US Agent Details

Mike Ryan Business: Simply Shipped, LLc Email: simplyshipped.agent@gmail.com Phone: (414) 3264114

Related Public Records

Same Entity

Shenzhen IONKA Medical Technology Co., Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3026132991. Last updated year: 2026. Please use registration number 3026132991 when referencing this establishment in official correspondence.