FDA 510(k) Applications Submitted by Shenzhen Kaiyan Medical Equipment Co., Ltd
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K240089 |
01/12/2024 |
Face Patches (MT-12MA, MT-12MC) |
Shenzhen Kaiyan Medical Equipment Co., Ltd |
| K250532 |
02/24/2025 |
Solawave 2-in-1 Skincare Mini (Model: 61043) |
Shenzhen Kaiyan Medical Equipment Co., Ltd |
| K250761 |
03/13/2025 |
KALA Therapy Wand (Model: KALA-03) |
SHENZHEN KAIYAN MEDICAL EQUIPMENT CO., LTD |
| K251017 |
04/02/2025 |
CurrentBody Skin Dual Light Hair Growth Helmet (model: MZ-07A) |
Shenzhen Kaiyan Medical Equipment Co., Ltd |
| K231321 |
05/08/2023 |
Nooance Led And Laser Helmet |
Shenzhen Kaiyan Medical Equipment Co., Ltd |
| K241933 |
07/02/2024 |
HIGHERDOSE Red and Infrared Light Mask (MK66-L) |
Shenzhen Kaiyan Medical Equipment Co., Ltd |
| K241947 |
07/03/2024 |
EnergyLounger (TY-01) |
Shenzhen Kaiyan Medical Equipment Co., Ltd |
| K242363 |
08/09/2024 |
HIGHERDOSE Red Light Hat (HG-120K) |
Shenzhen Kaiyan Medical Equipment Co., Ltd |
| K242593 |
08/30/2024 |
CurrentBodyÖ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N) |
Shenzhen Kaiyan Medical Equipment Co., Ltd |
| K232863 |
09/15/2023 |
Radiant Renewal Skincare Wand (HD-15, HD-15A) |
Shenzhen Kaiyan Medical Equipment Co., Ltd |
| K233556 |
11/06/2023 |
LED Eye mask (EY-20R, A20, EY-20N) |
Shenzhen Kaiyan Medical Equipment Co., Ltd |
| K250966 |
03/31/2025 |
CurrentBody SkinÖ LED Light Therapy Mask Series 2 (MK-90H) |
Shenzhen Kaiyan Medical Equipment Co., Ltd |
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