Trudermal Halo Hair Growth System (M-180A); Aduro Hair Growth (M-130,M-300)
FDA 510(k) K253669 · Shenzhen Kaiyan Medical Equipment Co., Ltd.
510(k) numberK253669
Submission
- Device name
- Trudermal Halo Hair Growth System (M-180A); Aduro Hair Growth (M-130,M-300)
- Applicant
- Shenzhen Kaiyan Medical Equipment Co., Ltd.
Shenzhen, CN - Received
- November 21, 2025
- Decision date
- January 23, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OAP – Laser, Comb, Hair
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5500
- Specialty
- Physical Medicine
Promote hair growth in males with androgenic alopecia and norwood hamilton classification of iia to v
Other 510(k)s with product code OAP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261675 | CHZL Red Light Therapy Hair Growth Cap (Model(s):CHZL-120BK-L52D,CHZL-120BK-L53D,CHZL-120…OAP · Traditional | Shenzhen Chuanghong Zhilian Technology Co., Ltd. | 07/17/2026SE |
| K261253 | Laser Hair Growth Devices (HR-H1, HR-H2, HR-H3, HR-H4, HR-H5, HR-H6, HR-H7, HR-H8…OAP · Traditional | Ziree Co., Ltd. | 06/26/2026SE |
| K260899 | Laser Hair Growth Device (F21151, F21152, F21153, F21154, F21155, F21156, F21157…OAP · Traditional | Zdeer Technology (Henan) Co., Ltd. | 06/16/2026SE |
| K253231 | Laser Hair Growth System (Laser Cap 128, Laser Helmet 272, Laser Helmet 352, Laser…OAP · Traditional | Hubei Yjt Technology Co.,Ltd | 06/16/2026SE |
| K251684 | Alma TED+ SystemOAP · Traditional | Alma Lasers, Inc. | 06/05/2026SE |
| K253349 | Hair Regrowth Cap (Model: T-119-HRC)OAP · Traditional | Light Tree Ventures Europe B.V. | 12/24/2025SE |
| K252414 | Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1)OAP · Traditional | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 10/30/2025SE |
| K252325 | Hair Growth Laser CapOAP · Traditional | Cosmo Far East Technology Limited | 10/22/2025SE |
| K251017 | CurrentBody Skin Dual Light Hair Growth Helmet (model: MZ-07A)OAP · Traditional | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 06/17/2025SE |
| K250467 | Red Light Hair Growth Cap (LP-RJVGRW-BLK)OAP · Traditional | Shenzhen Idea Light Limited | 06/05/2025SE |
More from Shenzhen Idea Light Limited
| 510(k) | Device | Decision |
|---|---|---|
| K253932 | FACEGYM Pro Device (HD-109)NFO · Traditional | 07/23/2026SE |
| K254025 | LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)OHS · Traditional | 06/16/2026SE |
| K260688 | Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)OLI · Traditional | 05/04/2026SE |
| K260129 | Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )OLI · Traditional | 04/15/2026SE |
| K253878 | LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001)OLP · Traditional | 03/04/2026SE |
| K252603 | HIGHERDOSE Body Sculptor (Model: GS-03)OHS · Traditional | 01/28/2026SE |
| K252414 | Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1)OAP · Traditional | 10/30/2025SE |
| K252272 | ORA Method LED Gua Sha (GS-04)OHS · Traditional | 10/09/2025SE |
| K251781 | Kala Mini 2.0 (KALA-04)OHS · Traditional | 09/04/2025SE |
| K251012 | TRUDERMAL Pro (ZLD-390)OHS · Traditional | 08/14/2025SE |
Questions and answers
When was Trudermal Halo Hair Growth System (M-180A); Aduro Hair Growth (M-130,M-300) cleared by the FDA?
Trudermal Halo Hair Growth System (M-180A); Aduro Hair Growth (M-130,M-300) (K253669) received a 510(k) decision of Substantially Equivalent on January 23, 2026, 63 days after the submission was received.
What is the product code of K253669?
The FDA product code is OAP – Laser, Comb, Hair, a Class II (moderate risk) device regulated under 21 CFR 890.5500.