Medical Device Manufacturer · CN , Shenzhen

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

20 submissions · 20 cleared · Since 2023
Official Website
20
Total
20
Cleared
0
Denied

FDA 510(k) cleared devices by Shenzhen Kaiyan Medical Equipment... General & Plastic Surgery ✕

20 devices
1-20 of 20
Cleared Mar 04, 2026
LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001)
K253878 · OLP
General & Plastic Surgery · 90d
Cleared Jan 28, 2026
HIGHERDOSE Body Sculptor (Model: GS-03)
K252603 · OHS
General & Plastic Surgery · 163d
Cleared Jan 23, 2026
TRUDERMAL HALO HAIR GROWTH SYSTEM (M-180A)
K253669 · OAP
General & Plastic Surgery · 63d
Cleared Oct 30, 2025
Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1)
K252414 · OAP
General & Plastic Surgery · 90d
Cleared Oct 09, 2025
ORA Method LED Gua Sha (GS-04)
K252272 · OHS
General & Plastic Surgery · 79d
Cleared Sep 04, 2025
KALA MINI 2.0 (KALA-04)
K251781 · OHS
General & Plastic Surgery · 85d
Cleared Aug 14, 2025
TRUDERMAL Pro (ZLD-390)
K251012 · OHS
General & Plastic Surgery · 134d
Cleared Jul 11, 2025
KALA Therapy Wand (Model: KALA-03)
K250761 · OHS
General & Plastic Surgery · 120d
Cleared Jun 25, 2025
CurrentBody Skin™ LED Light Therapy Mask Series 2 (MK-90H)
K250966 · OHS
General & Plastic Surgery · 86d
Cleared Jun 17, 2025
CurrentBody Skin Dual Light Hair Growth Helmet (model: MZ-07A)
K251017 · OAP
General & Plastic Surgery · 76d
Cleared May 30, 2025
KALA Red Light Face Mask (KALA-01)
K250581 · OHS
General & Plastic Surgery · 92d
Cleared May 22, 2025
Solawave 2-in-1 Skincare Mini (Model: 61043)
K250532 · OHS
General & Plastic Surgery · 87d
Cleared Mar 03, 2025
EnergyLounger (TY-01)
K241947 · OHS
General & Plastic Surgery · 243d
Cleared Feb 14, 2025
CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F,...
K242593 · OHS
General & Plastic Surgery · 168d
Cleared Nov 20, 2024
HIGHERDOSE Red Light Hat (HG-120K)
K242363 · OAP
General & Plastic Surgery · 103d
Cleared Sep 27, 2024
HIGHERDOSE Red and Infrared Light Mask (MK66-L)
K241933 · OHS
General & Plastic Surgery · 87d
Cleared Apr 10, 2024
Face Patches (MT-12MA, MT-12MC)
K240089 · OHS
General & Plastic Surgery · 89d
Cleared Jan 04, 2024
LED Eye mask (EY-20R, A20, EY-20N)
K233556 · OHS
General & Plastic Surgery · 59d
Cleared Dec 13, 2023
Radiant Renewal Skincare Wand (HD-15, HD-15A)
K232863 · OHS
General & Plastic Surgery · 89d
Cleared Jul 31, 2023
Nooance Led And Laser Helmet
K231321 · OAP
General & Plastic Surgery · 84d
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