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Shenzhen Kaiyan Medical Equipment Co., Ltd.

FDA 510(k) & PMA Approved Dispositivos — 24 products

Total de dispositivos24
Categorias0
Última decisão da FDA
TipoNúmeroNome do dispositivoCódigoDataAções
510(k) K253932 FACEGYM Pro Device (HD-109)NFO2026-07-23 Ver
510(k) K254025 LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)OHS2026-06-16 Ver
510(k) K260688 Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)OLI2026-05-04 Ver
510(k) K260129 Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )OLI2026-04-15 Ver
510(k) K253878 LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001)OLP2026-03-04 Ver
510(k) K252603 HIGHERDOSE Body Sculptor (Modelo: GS-03)OHS2026-01-28 Ver
510(k) K253669 TRUDERMAL HALO HAIR GROWTH SYSTEM (M-180A); ADURO HAIR GROWTH (M-130,M-300)OAP2026-01-23 Ver
510(k) K252414 Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1)OAP2025-10-30 Ver
510(k) K252272 ORA Method LED Gua Sha (GS-04)OHS2025-10-09 Ver
510(k) K251781 KALA MINI 2.0 (KALA-04)OHS2025-09-04 Ver
510(k) K251012 TRUDERMAL Pro (ZLD-390)OHS2025-08-14 Ver
510(k) K250761 KALA Therapy Wand (Model: KALA-03)OHS2025-07-11 Ver
510(k) K250966 CurrentBody Skin™ LED Light Therapy Mask Series 2 (MK-90H)OHS2025-06-25 Ver
510(k) K251017 CurrentBody Skin Dual Light Hair Growth Helmet (model: MZ-07A)OAP2025-06-17 Ver
510(k) K250581 KALA Red Light Face Mask (KALA-01)OHS2025-05-30 Ver
510(k) K250532 Solawave 2-in-1 Skincare Mini (Model: 61043)OHS2025-05-22 Ver
510(k) K241947 EnergyLounger (TY-01)OHS2025-03-03 Ver
510(k) K242593 CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N)OHS2025-02-14 Ver
510(k) K242363 HIGHERDOSE Red Light Hat (HG-120K)OAP2024-11-20 Ver
510(k) K241933 HIGHERDOSE Red and Infrared Light Mask (MK66-L)OHS2024-09-27 Ver
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