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Shenzhen Kaiyan Medical Equipment Co., Ltd. FDA Approvals

0 new drug approvals and 24 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product
FACEGYM Pro Device (HD-109)510(k)Jul 23, 2026Neurology
LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)510(k)Jun 16, 2026General, Plastic Surgery
Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)510(k)May 4, 2026General, Plastic Surgery
Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )510(k)Apr 15, 2026General, Plastic Surgery
LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001)510(k)Mar 4, 2026General, Plastic Surgery
HIGHERDOSE Body Sculptor (Model: GS-03)510(k)Jan 28, 2026General, Plastic Surgery
TRUDERMAL HALO HAIR GROWTH SYSTEM (M-180A); ADURO HAIR GROWTH (M-130,M-300)510(k)Jan 23, 2026Physical Medicine
Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1)510(k)Oct 30, 2025Physical Medicine
ORA Method LED Gua Sha (GS-04)510(k)Oct 9, 2025General, Plastic Surgery
KALA MINI 2.0 (KALA-04)510(k)Sep 4, 2025General, Plastic Surgery
TRUDERMAL Pro (ZLD-390)510(k)Aug 14, 2025General, Plastic Surgery
KALA Therapy Wand (Model: KALA-03)510(k)Jul 11, 2025General, Plastic Surgery
CurrentBody Skin™ LED Light Therapy Mask Series 2 (MK-90H)510(k)Jun 25, 2025General, Plastic Surgery
CurrentBody Skin Dual Light Hair Growth Helmet (model: MZ-07A)510(k)Jun 17, 2025Physical Medicine
KALA Red Light Face Mask (KALA-01)510(k)May 30, 2025General, Plastic Surgery
Solawave 2-in-1 Skincare Mini (Model: 61043)510(k)May 22, 2025General, Plastic Surgery
EnergyLounger (TY-01)510(k)Mar 3, 2025General, Plastic Surgery
CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N)510(k)Feb 14, 2025General, Plastic Surgery
HIGHERDOSE Red Light Hat (HG-120K)510(k)Nov 20, 2024Physical Medicine
HIGHERDOSE Red and Infrared Light Mask (MK66-L)510(k)Sep 27, 2024General, Plastic Surgery
Face Patches (MT-12MA, MT-12MC)510(k)Apr 10, 2024General, Plastic Surgery
LED Eye mask (EY-20R, A20, EY-20N)510(k)Jan 4, 2024General, Plastic Surgery
Radiant Renewal Skincare Wand (HD-15, HD-15A)510(k)Dec 13, 2023General, Plastic Surgery
Nooance Led And Laser Helmet510(k)Jul 31, 2023Physical Medicine

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