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

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