Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007744197

FEI Number

3007744197

Entity Name

Shenzhen Siken 3D Technology Development Co., Ltd.

City/State/Country

Dongguan Guangdong, CN

Establishment Address

6th Floor, Building E26, Tian'an Shenchuang Valley, Fenggang Town, Dongguan Guangdong 523707, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Shenzhen Siken 3D Technology Development Co., Ltd. (Owner Number: 10029432)

Owner / Operator Contact Address

Room 1104, Building 2, Jiayu Environmental Protection Factory, No. 162, Shajiang Road, Xitou Community, Songgang Street, Bao'an District, Shenzhen, CN-GD 518105, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K243040

PMA Number

N/A

All Registered Proprietary Names

Massager, Multiple types Multi-functional beauty device, SKB-1909 IPL Cooling Hair Removal Device, model: SKB-2008, SKB-2128, SKB-2188, SKB-2118 IPL Cooling Hair Removal Device, model: SKB-1808, SKB-2308, SKB-2128N, SKB-2188N Multi-functional Facial Beauty Device(SKB-1703, SKB-1803, SKB-1809, SKB-1909, SKB-2109, SKB-2129, SKB-2208PRO, SKB-2209 Penguin LED Sculpt Pro(Prospera DL039 reference to SKB-2209) Multi-functional Facial Beauty Device(SKB-1703,SKB-1803,SKB-1909,SKB-2003,SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209) LED Light Therapy Mask(Models: SKB-1818P, SKB-1918, SKB-1918P, SKB-1918PLUS) LED Light Therapy Mask ( Models: SKB-2318L, SKB-2318P, SKB-2318PRO, IN-FM002, SKB-2418)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2009-05-13
OHT	Light Based Over-The-Counter Hair Removal	General, Plastic Surgery	Class 2	878.4810	2022-12-04
OHT	Light Based Over-The-Counter Hair Removal	General, Plastic Surgery	Class 2	878.4810	2023-11-20
OLP	Over-The-Counter Powered Light Based Laser For Acne	General, Plastic Surgery	Class 2	878.4810	2026-01-06
OHS	Light Based Over The Counter Wrinkle Reduction	General, Plastic Surgery	Class 2	878.4810	2026-01-06
NFO	Stimulator, Transcutaneous Electrical, Aesthetic Purposes	Neurology	Class 2	882.5890	2026-01-06
OHS	Light Based Over The Counter Wrinkle Reduction	General, Plastic Surgery	Class 2	878.4810	2024-12-22

Official Correspondent

No official correspondent registered.

US Agent Details

Charles Mack Business: IRC USA Email: ircfda@gmail.com Phone: (931) 6254938

Related Public Records

Same Entity

Shenzhen Siken 3D Technology Development 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 3007744197. Last updated year: 2026. Please use registration number 3007744197 when referencing this establishment in official correspondence.