FACEGYM Pro Device (HD-109)
FDA 510(k) K253932 · Shenzhen Kaiyan Medical Equipment Co., Ltd.
510(k) numberK253932
Submission
- Device name
- FACEGYM Pro Device (HD-109)
- Applicant
- Shenzhen Kaiyan Medical Equipment Co., Ltd.
Shenzhen, CN - Received
- December 9, 2025
- Decision date
- July 23, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was FACEGYM Pro Device (HD-109) cleared by the FDA?
FACEGYM Pro Device (HD-109) (K253932) received a 510(k) decision of Substantially Equivalent on July 23, 2026, 226 days after the submission was received.
What is the product code of K253932?
The FDA product code is NFO – Stimulator, Transcutaneous Electrical, Aesthetic Purposes, a Class II (moderate risk) device regulated under 21 CFR 882.5890.