Shenzhen Kaiyan Medical Equipment Co., Ltd. - FDA 510(k) Cleared Devi...

Shenzhen Kaiyan Medical Equipment Co., Ltd. is a medical device manufacturer based in Shenzhen, China. The company specializes in light therapy devices for clinical and aesthetic applications.

Kaiyan Medical has received 21 FDA 510(k) clearances from 21 total submissions since 2023. All cleared devices fall within the General & Plastic Surgery category. The company maintains active regulatory status, with its most recent clearance in 2026.

The company's cleared device portfolio includes LED light therapy masks, hair growth helmets, and advanced light-based aesthetic treatment systems. These devices reflect Kaiyan Medical's focus on non-invasive light therapy technologies for dermatological and cosmetic applications.

Explore the complete list of device names, product codes, and clearance dates in the database.

510(k) submissions have been managed by Higherdose, LLC as regulatory consultant.