Medical Device Manufacturer · CN , Shenzhen

Shenzhen Kaiyan Medical Equipment Co., Ltd.

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

Shenzhen Kaiyan Medical Equipment Co., Ltd. — FDA 510(k) Submissions

Shenzhen Kaiyan Medical Equipment Co., Ltd. has submitted 20 FDA 510(k) premarket notifications since 2023, of which 20 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Light Based Over The Counter Wrinkle Reduction, Laser, Comb, Hair, Over-the-counter Powered Light Based Laser For Acne . Use the specialty filter in the sidebar to narrow results.

20 devices
1–20 of 20
LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001)
K253878 · OLP Over-the-counter Powered... · General & Plastic Surgery
Mar 2026 90d
HIGHERDOSE Body Sculptor (Model: GS-03)
K252603 · OHS Light Based Over The... · General & Plastic Surgery
Jan 2026 163d
TRUDERMAL HALO HAIR GROWTH SYSTEM (M-180A); ADURO HAIR GROWTH (M-130,M-300)
K253669 · OAP Laser, Comb, Hair · General & Plastic Surgery
Jan 2026 63d
Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1)
K252414 · OAP Laser, Comb, Hair · General & Plastic Surgery
Oct 2025 90d
ORA Method LED Gua Sha (GS-04)
K252272 · OHS Light Based Over The... · General & Plastic Surgery
Oct 2025 79d
KALA MINI 2.0 (KALA-04)
K251781 · OHS Light Based Over The... · General & Plastic Surgery
Sep 2025 85d
TRUDERMAL Pro (ZLD-390)
K251012 · OHS Light Based Over The... · General & Plastic Surgery
Aug 2025 134d
KALA Therapy Wand (Model: KALA-03)
K250761 · OHS Light Based Over The... · General & Plastic Surgery
Jul 2025 120d
CurrentBody Skin? LED Light Therapy Mask Series 2 (MK-90H)
K250966 · OHS Light Based Over The... · General & Plastic Surgery
Jun 2025 86d
CurrentBody Skin Dual Light Hair Growth Helmet (model: MZ-07A)
K251017 · OAP Laser, Comb, Hair · General & Plastic Surgery
Jun 2025 76d
KALA Red Light Face Mask (KALA-01)
K250581 · OHS Light Based Over The... · General & Plastic Surgery
May 2025 92d
Solawave 2-in-1 Skincare Mini (Model: 61043)
K250532 · OHS Light Based Over The... · General & Plastic Surgery
May 2025 87d
EnergyLounger (TY-01)
K241947 · OHS Light Based Over The... · General & Plastic Surgery
Mar 2025 243d
CurrentBody? LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N)
K242593 · OHS Light Based Over The... · General & Plastic Surgery
Feb 2025 168d
HIGHERDOSE Red Light Hat (HG-120K)
K242363 · OAP Laser, Comb, Hair · General & Plastic Surgery
Nov 2024 103d
HIGHERDOSE Red and Infrared Light Mask (MK66-L)
K241933 · OHS Light Based Over The... · General & Plastic Surgery
Sep 2024 87d
Face Patches (MT-12MA, MT-12MC)
K240089 · OHS Light Based Over The... · General & Plastic Surgery
Apr 2024 89d
LED Eye mask (EY-20R, A20, EY-20N)
K233556 · OHS Light Based Over The... · General & Plastic Surgery
Jan 2024 59d
Radiant Renewal Skincare Wand (HD-15, HD-15A)
K232863 · OHS Light Based Over The... · General & Plastic Surgery
Dec 2023 89d
Nooance Led And Laser Helmet
K231321 · OAP Laser, Comb, Hair · General & Plastic Surgery
Jul 2023 84d
Filters
Filter by Specialty
All20 General & Plastic Surgery 20