Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

FACEGYM Pro Device (HD-109)

K-Number: K253932 · 2026-07-23

ApplicantShenzhen Kaiyan Medical Equipment Co., Ltd.
Decision Date2026-07-23
Product CodeNFO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

FACEGYM Pro Device (HD-109) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Kaiyan Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2026-07-23 under 510(k) number K253932. The device is classified under product code NFO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FACEGYM Pro Device (HD-109)?

FACEGYM Pro Device (HD-109) is a medical device that received FDA 510(k) clearance on 2026-07-23. The listed applicant is Shenzhen Kaiyan Medical Equipment Co., Ltd.. The 510(k) number is K253932.

When did FACEGYM Pro Device (HD-109) receive FDA 510(k) clearance?

FACEGYM Pro Device (HD-109) received FDA 510(k) clearance on 2026-07-23, under 510(k) number K253932.

Who is the listed applicant for FACEGYM Pro Device (HD-109)?

The FDA 510(k) record lists Shenzhen Kaiyan Medical Equipment Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FACEGYM Pro Device (HD-109)?

The FDA product code for FACEGYM Pro Device (HD-109) is NFO.

Other records listing Shenzhen Kaiyan Medical Equipment Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254025LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)K260688Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)K260129Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )K253878LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001)K252603HIGHERDOSE Body Sculptor (Model: GS-03)K253669TRUDERMAL HALO HAIR GROWTH SYSTEM (M-180A); ADURO HAIR GROWTH (M-130,M-300)

View all 24 devices →

Related Devices (Code: NFO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260179VITA Multi-Function Head Brush (TB-2343F, TB-2442F)Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.K260895Ulike Clear Zero (YC10 BU)Guangxi Ulike Medical Technology Co., Ltd.K252621DeepSkin (DEP100)El Global Trade, Ltd.K252187Aura Glide (FC40)Aura Medical, LLCK252146Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003 SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209)Shenzhen Siken 3D Technology Development Co., Ltd.K250618Medi Lift Essential Eye MaskYa-Man, Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑