Shenzhen Kaiyan Medical Equipment Co., Ltd.
FDA 510(k) & PMA Approved Devices — 24 products
Total Devices24
Categories5
Latest FDA decision2026-07-23
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K253932 | FACEGYM Pro Device (HD-109) | NFO | 2026-07-23 | View |
| 510(k) | K254025 | LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H) | OHS | 2026-06-16 | View |
| 510(k) | K260688 | Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C) | OLI | 2026-05-04 | View |
| 510(k) | K260129 | Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro ) | OLI | 2026-04-15 | View |
| 510(k) | K253878 | LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001) | OLP | 2026-03-04 | View |
| 510(k) | K252603 | HIGHERDOSE Body Sculptor (Model: GS-03) | OHS | 2026-01-28 | View |
| 510(k) | K253669 | TRUDERMAL HALO HAIR GROWTH SYSTEM (M-180A); ADURO HAIR GROWTH (M-130,M-300) | OAP | 2026-01-23 | View |
| 510(k) | K252414 | Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1) | OAP | 2025-10-30 | View |
| 510(k) | K252272 | ORA Method LED Gua Sha (GS-04) | OHS | 2025-10-09 | View |
| 510(k) | K251781 | KALA MINI 2.0 (KALA-04) | OHS | 2025-09-04 | View |
| 510(k) | K251012 | TRUDERMAL Pro (ZLD-390) | OHS | 2025-08-14 | View |
| 510(k) | K250761 | KALA Therapy Wand (Model: KALA-03) | OHS | 2025-07-11 | View |
| 510(k) | K250966 | CurrentBody Skin™ LED Light Therapy Mask Series 2 (MK-90H) | OHS | 2025-06-25 | View |
| 510(k) | K251017 | CurrentBody Skin Dual Light Hair Growth Helmet (model: MZ-07A) | OAP | 2025-06-17 | View |
| 510(k) | K250581 | KALA Red Light Face Mask (KALA-01) | OHS | 2025-05-30 | View |
| 510(k) | K250532 | Solawave 2-in-1 Skincare Mini (Model: 61043) | OHS | 2025-05-22 | View |
| 510(k) | K241947 | EnergyLounger (TY-01) | OHS | 2025-03-03 | View |
| 510(k) | K242593 | CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N) | OHS | 2025-02-14 | View |
| 510(k) | K242363 | HIGHERDOSE Red Light Hat (HG-120K) | OAP | 2024-11-20 | View |
| 510(k) | K241933 | HIGHERDOSE Red and Infrared Light Mask (MK66-L) | OHS | 2024-09-27 | View |
No matching devices.
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