FACEGYM Pro Device (HD-109)— 510(k) K253932

Name: FDA 510(k) clearance K253932
Creator: U.S. Food and Drug Administration
Published: 2026-07-23

Substantially Equivalent

Shenzhen Kaiyan Medical Equipment Co., Ltd.

FDA 510(k) clearance K253932 for FACEGYM Pro Device (HD-109), Substantially Equivalent on 2026-07-23. Applicant: Shenzhen Kaiyan Medical Equipment Co., Ltd.. Device class: 2.

Summary

Shenzhen Kaiyan Medical Equipment's FACEGYM Pro Device (HD-109) is filed under NFO, transcutaneous electrical stimulators for aesthetic purposes. The record gives the model as HD-109 but no specs.

Class II, 21 CFR 882.5890. Neurology is both the classification panel and the review panel, and it came in as a Traditional 510(k).

Shenzhen Kaiyan filed from Shenzhen, China. Review took 226 calendar days (December 9, 2025 to July 23, 2026).

Clearance details

Applicant: Shenzhen Kaiyan Medical Equipment Co., Ltd.
Product code: Product code NFO
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 2025-12-09
Decision date: 2026-07-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

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