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DONGGUAN BOYUAN INTELLIGENT TECHNOLOGY CO., LTD.

China · Dongguan

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Canada, Australia — 3 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 7 registration records and 5 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

3 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

2active ARTG entries

IIa 2

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 States7 registration records, 5 510(k), 0 PMA

Brazil0 confirmed, 1 excluded

Manufacturer names merged into this page: DONGGUAN BOYUAN INTELLIGENT TECHNOLOGY CO., LTD · DONGGUAN BOYUAN INTELLIGENT TECHNOLOGY CO., LTD.

Same-named companies — This database also contains companies with near-identical names: Shenzhen Boyuan Intelligent Electronic Technology Co., Ltd.. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

12021 · K210119

22024 · K241857

22025 · K250253

FDA listed device types

Lamp, Infrared, Therapeutic Heating 1Light Based Over The Counter Wrinkle Reduction 1Over-The-Counter Powered Light Based Laser For Acne 1Light Based Over-The-Counter Hair Removal 1Laser, Comb, Hair 1Brush, Dermabrasion, Manual 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K250253	IPL Hair Removal Device (KCA511/KCA516/KCA522)	2025-05-06
US	K250308	Hair Growth Device (KCA441-200, KCA441-120, KCA441-88, KCA441-56, KCA441-200S, KCA441-120S, KCA441-88S, KCA441-56S, KCA451-200, KCA451-120, KCA451-88, KCA451-56, KCA451-200S, KCA451-120S, KCA451-88S, KCA451-56S)	2025-04-29
US	K241857	LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293)	2024-10-11

DONGGUAN BOYUAN INTELLIGENT TECHNOLOGY 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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