Data / Medical devices / China / Dongguan Boyuan Intelligent Technology Co., Ltd
Dongguan Boyuan Intelligent Technology Co., Ltd: FDA-registered device maker in DONGGUAN CITY Guangdong, China, 6 510(k) clearances
Dongguan Boyuan Intelligent Technology Co., Ltd is registered with the FDA (registration 3030234143) in DONGGUAN CITY Guangdong, China. It lists 6 device types. The FDA files 6 510(k) clearances under its listings, the newest dated May 6, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3030234143
- Address
- Room 801, Building 3, No. 3,Kuiqiao Road, Puxin Lake Tangxia Town, DONGGUAN CITY Guangdong, China, 523000
- Owner or operator
- Dongguan Boyuan Intelligent Technology Co., Ltd (10089324)
- Roles
- Manufacturer
- First device listed
- November 28, 2023
- Registered through
- 2026
- Brand names listed
- Hair Growth Device KCA441-200, KCA441-120, KCA441-88, KCA441-56, KCA441- 200S, KCA441-120S, KCA441-88S, KCA441-56S, IPL Hair Removal Device (KCA511/KCA516/KCA522) THE LASE COLLECTION KCA511 Meridian MHW100, IPL Hair Removal Device( KCA423, KCA439), KCA450, KCA446, KCA504, KCA505, KCA506, KCA507, KCA508, KCA509, KCA501, KCA423, KCA448, KCA449, KCA502, KCA521, KCA451-200, KCA451-120, KCA451-88, KCA451-56, KCA451-200S, KCA451- 120S, KCA451-88S, KCA451-56S THE LASE COLLECTION, KCA512 KCA514, KFB302 Skin Booster Device, KFB247, LED Beauty Mask KFB265, KFB307, KFB309, KFB302, KFB310 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Brush, Dermabrasion, Manual | GED | 1 | Manufacturer | accessdata.fda.gov |
| Lamp, Infrared, Therapeutic Heating | ILY | 2 | Manufacturer | accessdata.fda.gov |
| Laser, Comb, Hair | OAP | 2 | Manufacturer | accessdata.fda.gov |
| Light Based Over The Counter Wrinkle Reduction | OHS | 2 | Manufacturer | accessdata.fda.gov |
| Light Based Over-The-Counter Hair Removal | OHT | 2 | Manufacturer | accessdata.fda.gov |
| Over-The-Counter Powered Light Based Laser For Acne | OLP | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 6, 2025 | K250253 | IPL Hair Removal Device (KCA511/KCA516/KCA522) | OHT | Substantially Equivalent | Dongguan Boyuan Intelligent Technology Co.,Ltd | accessdata.fda.gov |
| April 29, 2025 | 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) | OAP | Substantially Equivalent | Dongguan Boyuan Intelligent Technology Co.,Ltd | accessdata.fda.gov |
| October 11, 2024 | K241857 | LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293) | OHS | Substantially Equivalent | Dongguan Boyuan Intelligent Technology Co.,Ltd | accessdata.fda.gov |
| April 3, 2024 | K240282 | IPL Hair Removal Device (model: KCA450, KCA446, KCA504, KCA505, KCA506, KCA507, KCA508, KCA509, KCA501, KCA423, KCA448, KCA449, KCA502, KCA521) | OHT | Substantially Equivalent | Dongguan Boyuan Intelligent Technology Co.,Ltd | accessdata.fda.gov |
| October 11, 2022 | K222432 | IPL Hair Removal Device, Model(s): KCA423, KCA437, KCA439 | OHT | Substantially Equivalent | Hunan Guangye Biotechnology Co., Ltd. | accessdata.fda.gov |
| July 19, 2022 | K221151 | Beauty LED Mask, Model: KFB265 | OHS | Substantially Equivalent | Hunan Guangye Biotechnology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Laser, Comb, Hair
- All makers of Light Based Over-The-Counter Hair Removal
- All makers of Light Based Over The Counter Wrinkle Reduction
- All makers of Over-The-Counter Powered Light Based Laser For Acne
- All makers of Lamp, Infrared, Therapeutic Heating
- All makers of Brush, Dermabrasion, Manual
Updated May 6, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.