Company · CN
Shenzhen Kaiyan Medical Equipment Co., Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2023 to 2026. Name variants (Inc, Corp, punctuation) are merged.
24510(k) clearances (7 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 23, 2026 | K253932 | FACEGYM Pro Device (HD-109) Shenzhen Kaiyan Medical Equipment Co., Ltd., CN | NFO |
| Jun 16, 2026 | K254025 | LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H) Shenzhen Kaiyan Medical Equipment Co., Ltd., CN | OHS |
| May 4, 2026 | K260688 | Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C) Shenzhen Kaiyan Medical Equipment Co., Ltd., CN | OLI |
| Apr 15, 2026 | K260129 | Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro ) Shenzhen Kaiyan Medical Equipment Co., Ltd., CN | OLI |
| Mar 4, 2026 | K253878 | LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001) Shenzhen Kaiyan Medical Equipment Co., Ltd., CN | OLP |
| Jan 28, 2026 | K252603 | HIGHERDOSE Body Sculptor (Model: GS-03) Shenzhen Kaiyan Medical Equipment Co., Ltd., CN | OHS |
| Jan 23, 2026 | K253669 | TRUDERMAL HALO HAIR GROWTH SYSTEM (M-180A); ADURO HAIR GROWTH (M-130,M-300) Shenzhen Kaiyan Medical Equipment Co., Ltd., CN | OAP |
| Oct 30, 2025 | K252414 | Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1) Shenzhen Kaiyan Medical Equipment Co., Ltd., CN | OAP |
| Oct 9, 2025 | K252272 | ORA Method LED Gua Sha (GS-04) Shenzhen Kaiyan Medical Equipment Co., Ltd., CN | OHS |
| Sep 4, 2025 | K251781 | KALA MINI 2.0 (KALA-04) Shenzhen Kaiyan Medical Equipment Co., Ltd., CN | OHS |
| Aug 14, 2025 | K251012 | TRUDERMAL Pro (ZLD-390) Shenzhen Kaiyan Medical Equipment Co., Ltd., CN | OHS |
| Jul 11, 2025 | K250761 | KALA Therapy Wand (Model: KALA-03) Shenzhen Kaiyan Medical Equipment Co., Ltd., CN | OHS |
| Jun 25, 2025 | K250966 | CurrentBody Skin LED Light Therapy Mask Series 2 (MK-90H) Shenzhen Kaiyan Medical Equipment Co., Ltd., CN | OHS |
| Jun 17, 2025 | K251017 | CurrentBody Skin Dual Light Hair Growth Helmet (model: MZ-07A) Shenzhen Kaiyan Medical Equipment Co., Ltd., CN | OAP |
| May 30, 2025 | K250581 | KALA Red Light Face Mask (KALA-01) Shenzhen Kaiyan Medical Equipment Co., Ltd., CN | OHS |
| May 22, 2025 | K250532 | Solawave 2-in-1 Skincare Mini (Model: 61043) Shenzhen Kaiyan Medical Equipment Co., Ltd., CN | OHS |
| Mar 3, 2025 | K241947 | EnergyLounger (TY-01) Shenzhen Kaiyan Medical Equipment Co., Ltd., CN | OHS |
| Feb 14, 2025 | K242593 | CurrentBody LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N) Shenzhen Kaiyan Medical Equipment Co., Ltd., CN | OHS |
| Nov 20, 2024 | K242363 | HIGHERDOSE Red Light Hat (HG-120K) Shenzhen Kaiyan Medical Equipment Co., Ltd., CN | OAP |
| Sep 27, 2024 | K241933 | HIGHERDOSE Red and Infrared Light Mask (MK66-L) Shenzhen Kaiyan Medical Equipment Co., Ltd., CN | OHS |
| Apr 10, 2024 | K240089 | Face Patches (MT-12MA, MT-12MC) Shenzhen Kaiyan Medical Equipment Co., Ltd., CN | OHS |
| Jan 4, 2024 | K233556 | LED Eye mask (EY-20R, A20, EY-20N) Shenzhen Kaiyan Medical Equipment Co., Ltd., CN | OHS |
| Dec 13, 2023 | K232863 | Radiant Renewal Skincare Wand (HD-15, HD-15A) Shenzhen Kaiyan Medical Equipment Co., Ltd., CN | OHS |
| Jul 31, 2023 | K231321 | Nooance Led And Laser Helmet Shenzhen Kaiyan Medical Equipment Co., Ltd., CN | OAP |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||