Hair Growth System
FDA 510(k) K190685 · Xuzhou Kernel Medical Equipment Co., Ltd.
510(k) numberK190685
Submission
- Device name
- Hair Growth System
- Applicant
- Xuzhou Kernel Medical Equipment Co., Ltd.
Suzhou, CN - Received
- March 18, 2019
- Decision date
- July 26, 2019
- 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 |
| K253669 | Trudermal Halo Hair Growth System (M-180A); Aduro Hair Growth (M-130,M-300)OAP · Traditional | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 01/23/2026SE |
| 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 |
More from Shenzhen Kaiyan Medical Equipment Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K261775 | Uv Phototherapy (KN-4001A,KN-4001B,KN-4001AB) · Traditional | 07/21/2026SE |
| K242977 | 308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D…FTC · Traditional | 02/06/2025SE |
| K222751 | LED Light Therapy Device, KN-7000LGEX · Traditional | 02/01/2023SE |
| K200971 | 308nm Excimer SystemFTC · Traditional | 12/15/2020SE |
| K200929 | Hair Growth SystemOAP · Traditional | 06/03/2020SE |
| K181805 | UV PhototherapyFTC · Traditional | 01/11/2019SE |
| K160341 | Colposcope SystemHEX · Traditional | 09/14/2016SE |
| K132643 | UV PhototherapyFTC · Traditional | 01/30/2014SE |
Questions and answers
When was Hair Growth System cleared by the FDA?
Hair Growth System (K190685) received a 510(k) decision of Substantially Equivalent on July 26, 2019, 130 days after the submission was received.
What is the product code of K190685?
The FDA product code is OAP – Laser, Comb, Hair, a Class II (moderate risk) device regulated under 21 CFR 890.5500.