Capillus302, Capillus312, Capillus352
FDA 510(k) K162994 · Capillus, LLC
510(k) numberK162994
Submission
- Device name
- Capillus302, Capillus312, Capillus352
- Applicant
- Capillus, LLC
Miami, FL, US - Received
- October 27, 2016
- Decision date
- November 18, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|
| K192012 | Capillus 112, Capillus 244OAP · Special | 09/12/2019SE |
| K163170 | Capillus 82, Capillus 202, Capillus 272 Pro, 272 Office Pro, Capillus 302, Capillus 312…OAP · Traditional | 01/31/2017SE |
| K160285 | Capillus272 Pro, Capillus272 OfficePro, Capillus82, Capillus202OAP · Traditional | 04/25/2016SE |
| K153618 | Capillus202OAP · Special | 01/19/2016SE |
| K151516 | Capillus82OAP · Special | 08/21/2015SE |
| K150578 | Capillus 272 Office ProOAP · Traditional | 06/09/2015SE |
| K143199 | Capillus 272 ProOAP · Traditional | 01/29/2015SE |
Questions and answers
When was Capillus302, Capillus312, Capillus352 cleared by the FDA?
Capillus302, Capillus312, Capillus352 (K162994) received a 510(k) decision of Substantially Equivalent on November 18, 2016, 22 days after the submission was received.
What is the product code of K162994?
The FDA product code is OAP – Laser, Comb, Hair, a Class II (moderate risk) device regulated under 21 CFR 890.5500.