FDA 510(k) Applications Submitted by Alain Dijkstra
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K230042 |
01/06/2023 |
Q-Rejuvalight Pro Facewear (Model: P19-0023) |
Light Tree Ventures Europe B.V. |
| K240089 |
01/12/2024 |
Face Patches (MT-12MA, MT-12MC) |
Shenzhen Kaiyan Medical Equipment Co., Ltd |
| K230124 |
01/17/2023 |
LUSTRE ClearSkin Renew Pro Facewear Mask(Model: PR4001) |
Light Tree Ventures Europe B.V. |
| K220168 |
01/20/2022 |
Skin Care Beauty Mask (Model: MJ-06) |
Shenzhen Kaiyan Medical Co Ltd |
| K230336 |
02/07/2023 |
CurrentBody SkinÖ Led Hair Regrowth(Model: MZ-07) |
Light Tree Ventures Europe B.V. |
| K250532 |
02/24/2025 |
Solawave 2-in-1 Skincare Mini (Model: 61043) |
Shenzhen Kaiyan Medical Equipment Co., Ltd |
| K250581 |
02/27/2025 |
KALA Red Light Face Mask (KALA-01) |
Shenzhen Kaiyan Medical Equipment Co. Ltd. |
| K230597 |
03/03/2023 |
Aduro Comb (Model: SZ-22, SZ-22A, SZ-22B) |
Light Tree Ventures Europe B.V. |
| 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 |
| K241155 |
04/25/2024 |
Cold Sore Device (QPZ-03) |
Shenzhen Nuon Medical Equipment Co., Ltd |
| K231321 |
05/08/2023 |
Nooance Led And Laser Helmet |
Shenzhen Kaiyan Medical Equipment Co., Ltd |
| K241342 |
05/13/2024 |
Hair Growth Comb (SZ-23,SZ-23A) |
Shenzhen Nuon 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 |
| K221946 |
07/05/2022 |
LED Light Therapy Mask (model: MK66R-B) |
Light Tree Ventures Europe B.V. |
| K242151 |
07/23/2024 |
Radiant Renewal Skincare Wand (HD-44,HD-44A ,HD-44B,HD-44C, HD-69, HD-69A, HD-69B) |
Shenzhen Nuon Medical Equipment Co., Ltd |
| K222205 |
07/25/2022 |
Cold Sore Device (Model: QPZ-01) |
Light Tree Ventures Europe B.V. |
| K242363 |
08/09/2024 |
HIGHERDOSE Red Light Hat (HG-120K) |
Shenzhen Kaiyan Medical Equipment Co., Ltd |
| K202390 |
08/21/2020 |
Aduro Light Beauty Mask |
Shenzhen Kaiyan Medical 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 |
| K242700 |
09/09/2024 |
Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A, HD-73A, HD-73B, HD-116, HD-116A, HD-53A, HD-53B) |
Shenzhen Nuon Medical Equipment Co., Ltd |
| K232863 |
09/15/2023 |
Radiant Renewal Skincare Wand (HD-15, HD-15A) |
Shenzhen Kaiyan Medical Equipment Co., Ltd |
| K213024 |
09/21/2021 |
Oren LED Perioral Light Therapy System |
Shenzhen Kaiyan Medical Co Ltd |
| K203214 |
11/02/2020 |
DemarkQ WOW, DemarkQ POP |
Shenzhen Kaiyan Medical Co Ltd |
| K203271 |
11/06/2020 |
Aduro light therapy Handheld |
Shenzhen Kaiyan Medical CO LTD |
| K233556 |
11/06/2023 |
LED Eye mask (EY-20R, A20, EY-20N) |
Shenzhen Kaiyan Medical Equipment Co., Ltd |
| K223642 |
12/06/2022 |
LED Lip Perfector, model: ZC-05 |
Light Tree Ventures Europe B.V. |
| K223893 |
12/28/2022 |
Infrared Heat (Model: E0221) |
Light Tree Ventures Europe B.V. |
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