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Dongguan Boyuan Intelligent Technology Co.,Ltd

4 FDA records filed under this company name, from 2024 to 2025, in hair removal (OHT, 2), hair growth (OAP, 1), light for wrinkles (OHS, 1).

The applicant is the company that filed with FDA. It can be the brand you know or a manufacturer that makes devices sold under other brand names; the device name as filed often shows which. We don't merge different company names, so check the A–Z list for related entries.

Laser and IPL hair removal (mostly over-the-counter; 1 record says prescription use) (OHT, 2)

510(k) cleared

IPL Hair Removal Device (KCA511/KCA516/KCA522)

510(k) number
K250253
Applicant
Dongguan Boyuan Intelligent Technology Co.,Ltd
Product code
OHT: Light Based Over-The-Counter Hair Removal
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use, as filed

“IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.”

Copied from the text of FDA's 510(k) document (PDF, page 4), with line breaks removed.

FDA database recordFDA document (PDF)

510(k) cleared

IPL Hair Removal Device (model: KCA450, KCA446, KCA504, KCA505, KCA506, KCA507, KCA508, KCA509, KCA501, KCA423, KCA448, KCA449, KCA502, KCA521)

510(k) number
K240282
Applicant
Dongguan Boyuan Intelligent Technology Co.,Ltd
Product code
OHT: Light Based Over-The-Counter Hair Removal
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use

Not quoted here. The page with this statement is a scanned image whose text was machine-read, so we can't vouch for it word for word. Read FDA's PDF, page 4.

FDA database recordFDA document (PDF)

Laser and LED hair-growth caps, helmets and combs (1 record says prescription use) (OAP, 1)

510(k) cleared

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)

510(k) number
K250308
Applicant
Dongguan Boyuan Intelligent Technology Co.,Ltd
Product code
OAP: Laser, Comb, Hair
Regulation
21 CFR 890.5500, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use

Not quoted here. The statement contains words we couldn't confirm (a typo, run-together words or a reading error), and we don't correct FDA's text. Read FDA's PDF, page 4.

FDA database recordFDA document (PDF)

LED and light devices for wrinkles (OHS, 1)

510(k) cleared

LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293)

510(k) number
K241857
Applicant
Dongguan Boyuan Intelligent Technology Co.,Ltd
Product code
OHS: Light Based Over The Counter Wrinkle Reduction
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use

Not quoted here. We couldn't find a clean, complete statement in FDA's PDF, so we don't quote one. Read FDA's PDF.

FDA database recordFDA document (PDF)