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Kam Yuen Plastic Products , Ltd.

5 FDA records filed under this company name, from 2019 to 2026, in light for wrinkles (OHS, 1), hair removal (OHT, 2), hair growth (OAP, 2).

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.

LED and light devices for wrinkles (OHS, 1)

510(k) cleared

Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS Beauty Device A-902; Facial Mask LED & EMS Beauty Device A-907)

510(k) number
K260767
Applicant
Kam Yuen Plastic Products , 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)

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

510(k) cleared

Aimanfun Lumea Comfort, Model: A-2788, A-2789 and A-3588

510(k) number
K230107
Applicant
Kam Yuen Plastic Products , 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

“Aimanfun Lumea Comfort is an over-the-counter device intended for removal of unwanted body and/or facial hair.”

Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.

FDA database recordFDA document (PDF)

510(k) cleared

Aimanfun Lumea Comfort

510(k) number
K190820
Applicant
Kam Yuen Plastic Products , 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. 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)

Laser and LED hair-growth caps, helmets and combs (1 record says prescription use) (OAP, 2)

510(k) cleared

Laser Hair Growth Comb

510(k) number
K213027
Applicant
Kam Yuen Plastic Products , 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 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 3.

FDA database recordFDA document (PDF)

510(k) cleared

Laser hair growth helmet

510(k) number
K213025
Applicant
Kam Yuen Plastic Products , 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 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 3.

FDA database recordFDA document (PDF)