Medical Device Manufacturer · CN , Shenzhen

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

24 submissions · 24 cleared · Since 2023

Recent clearances: FACEGYM Pro Device (HD-109), LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H), Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)

Official Website

24

Total

24

Cleared

0

Denied

FDA 510(k) Regulatory Record - Shenzhen Kaiyan Medical Equipment Co., Ltd. General & Plastic Surgery ✕

23 devices

1-12 of 23

Cleared Jun 16, 2026

LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)

General & Plastic Surgery · 182d

Cleared May 04, 2026

Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)

General & Plastic Surgery · 62d

Cleared Apr 15, 2026

Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )

General & Plastic Surgery · 89d

Cleared Mar 04, 2026

LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001)

General & Plastic Surgery · 90d

Cleared Jan 28, 2026

HIGHERDOSE Body Sculptor (Model: GS-03)

General & Plastic Surgery · 163d

Cleared Jan 23, 2026

TRUDERMAL HALO HAIR GROWTH SYSTEM (M-180A)

General & Plastic Surgery · 63d

Cleared Oct 30, 2025

Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1)

General & Plastic Surgery · 90d

Cleared Oct 09, 2025

ORA Method LED Gua Sha (GS-04)

General & Plastic Surgery · 79d

Cleared Sep 04, 2025

KALA MINI 2.0 (KALA-04)

General & Plastic Surgery · 85d

Cleared Aug 14, 2025

TRUDERMAL Pro (ZLD-390)

General & Plastic Surgery · 134d

Cleared Jul 11, 2025

KALA Therapy Wand (Model: KALA-03)

General & Plastic Surgery · 120d

Cleared Jun 25, 2025

CurrentBody Skin™ LED Light Therapy Mask Series 2 (MK-90H)

General & Plastic Surgery · 86d