Shenzhen Kaiyan Medical Equipment Co., Ltd.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 20
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K253878 | LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001) | March 4, 2026 |
| K252603 | HIGHERDOSE Body Sculptor (Model: GS-03) | January 28, 2026 |
| K253669 | TRUDERMAL HALO HAIR GROWTH SYSTEM (M-180A); ADURO HAIR GROWTH (M-130,M-300) | January 23, 2026 |
| K252414 | Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1) | October 30, 2025 |
| K252272 | ORA Method LED Gua Sha (GS-04) | October 9, 2025 |
| K251781 | KALA MINI 2.0 (KALA-04) | September 4, 2025 |
| K251012 | TRUDERMAL Pro (ZLD-390) | August 14, 2025 |
| K250761 | KALA Therapy Wand (Model: KALA-03) | July 11, 2025 |
| K250966 | CurrentBody Skin LED Light Therapy Mask Series 2 (MK-90H) | June 25, 2025 |
| K251017 | CurrentBody Skin Dual Light Hair Growth Helmet (model: MZ-07A) | June 17, 2025 |
| K250581 | KALA Red Light Face Mask (KALA-01) | May 30, 2025 |
| K250532 | Solawave 2-in-1 Skincare Mini (Model: 61043) | May 22, 2025 |
| K241947 | EnergyLounger (TY-01) | March 3, 2025 |
| K242593 | CurrentBody LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N) | February 14, 2025 |
| K242363 | HIGHERDOSE Red Light Hat (HG-120K) | November 20, 2024 |
| K241933 | HIGHERDOSE Red and Infrared Light Mask (MK66-L) | September 27, 2024 |
| K240089 | Face Patches (MT-12MA, MT-12MC) | April 10, 2024 |
| K233556 | LED Eye mask (EY-20R, A20, EY-20N) | January 4, 2024 |
| K232863 | Radiant Renewal Skincare Wand (HD-15, HD-15A) | December 13, 2023 |
| K231321 | Nooance Led And Laser Helmet | July 31, 2023 |