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Shenzhen Siken 3D Technology Development Co., Ltd.

China · Dongguan Guangdong

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Brazil — 2 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

pendingnot queried

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

6listed device types

Class I 1Class II 5Class III 0

plus 8 registration records and 6 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class II 1

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States8 registration records, 6 510(k), 0 PMA

Brazil1 confirmed, 0 excluded

Manufacturer names merged into this page: Shenzhen Siken 3D Technology Development Co., Ltd. · SHENZHEN SIKEN 3D TECHNOLOGY DEVELOPMENT CO., LTD.

FDA 510(k) clearances by year

12017 · K163470

12022 · K222710

12023 · K232845

12024 · K243040

22025 · K252146

FDA listed device types

Lamp, Infrared, Therapeutic Heating 1Stimulator, Transcutaneous Electrical, Aesthetic Purposes 1Light Based Over The Counter Wrinkle Reduction 1Over-The-Counter Powered Light Based Laser For Acne 1Light Based Over-The-Counter Hair Removal 1Massager, Therapeutic, Electric 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K252146	Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003 SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209)	2025-12-23
US	K252142	Multi-functional Facial Beauty Device (SKB-1703,SKB-1803,SKB-1809, SKB-1909, SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209)	2025-12-05
US	K243040	LED Light Therapy Mask (SKB-1818P,SKB-1918,SKB-1918P,SKB-1918PLUS,SKB-2318L,SKB-2318P,SKB-2318PRO,IN-FM002, SKB-2418)	2024-12-20
BR	81632909005	MÁSCARA FACIAL COM FOTOTERAPIA	Class II

Shenzhen Siken 3D Technology Development Co., Ltd.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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