OAP
- 产品代码
- OAP
- 器械名称
- Laser, Comb, Hair
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 890.5500
- FDA 专业组
- Physical Medicine
- 上市路径
- 需提交 510(k) 上市前通告
- 该代码近三年的 510(k)
- 112 件
FDA 分类定义
Promote hair growth in males with androgenic alopecia and norwood hamilton classification of iia to v
该代码近三年的 510(k)（23 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 |
|---|---|---|---|
| K261675 | 2026-07-17 | Shenzhen Chuanghong Zhilian Technology | CHZL Red Light Therapy Hair Growth Cap (Model(s):CHZ 摘要 |
| K261253 | 2026-06-26 | Ziree Co., Ltd. | Laser Hair Growth Devices (HR-H1, HR-H2, HR-H3, HR-H 摘要 |
| K260899 | 2026-06-16 | Zdeer Technology (Henan) Co., Ltd. | Laser Hair Growth Device (F21151, F21152, F21153, F2 摘要 |
| K253231 | 2026-06-16 | Hubei Yjt Technology Co.,Ltd | Laser Hair Growth System (Laser Cap 128, Laser Helme 摘要 |
| K251684 | 2026-06-05 | Alma Lasers, Inc. | Alma TED+ System 摘要 |
| K253669 | 2026-01-23 | Shenzhen Kaiyan Medical Equipment Co., | TRUDERMAL HALO HAIR GROWTH SYSTEM (M-180A); ADURO HA 摘要 |
| K253349 | 2025-12-24 | Light Tree Ventures Europe B.V. | Hair Regrowth Cap (Model: T-119-HRC) 摘要 |
| K252414 | 2025-10-30 | Shenzhen Kaiyan Medical Equipment Co., | Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1) 摘要 |
| K252325 | 2025-10-22 | Cosmo Far East Technology Limited | Hair Growth Laser Cap 摘要 |
| K251017 | 2025-06-17 | Shenzhen Kaiyan Medical Equipment Co., | CurrentBody Skin Dual Light Hair Growth Helmet (mode 摘要 |
| K250467 | 2025-06-05 | Shenzhen Idea Light Limited | Red Light Hair Growth Cap (LP-RJVGRW-BLK) 摘要 |
| K250308 | 2025-04-29 | Dongguan Boyuan Intelligent Technology | Hair Growth Device (KCA441-200, KCA441-120, KCA441-8 摘要 |
| K242747 | 2024-12-11 | Foreo, Inc. | FAQ (302) 摘要 |
| K242619 | 2024-12-02 | Apira Science, Inc. | GroWell BT Hair Growth System (GW10042) 摘要 |
| K242363 | 2024-11-20 | Shenzhen Kaiyan Medical Equipment Co., | HIGHERDOSE Red Light Hat (HG-120K) 摘要 |
| K241342 | 2024-11-08 | Shenzhen Nuon Medical Equipment Co., L | Hair Growth Comb (SZ-23,SZ-23A) 摘要 |
| K242620 | 2024-11-01 | Shenzhen Breo Technology Co., Ltd. | Breo Laser Hair Growth Comb (Scalp 3L) 摘要 |
| K240472 | 2024-10-11 | Dongguan Tutamen Metalwork Co., Ltd. | PBM Hair Therapy Cap 摘要 |
| K240689 | 2024-09-17 | Telebrands Corporation | Robin's Egg 摘要 |
| K242441 | 2024-09-13 | Revian, Inc. | Revian Lyte (10011) 摘要 |
| K240456 | 2024-05-22 | Plm Worldwide, LLC D/B/A Phoenix Medic | Bosley Booster 128 Laser Cap; Bosley Booster 162 Las 摘要 |
| K240064 | 2024-02-07 | Wontech Co., Ltd. | Hair Boom Air / Ulike Hair UpUp / Hair Boom 69 / Hai 摘要 |
| K232356 | 2023-10-24 | Hubei Yjt Technology Co.,Ltd | Laser Cap, Model: Hat-01 摘要 |
FDA 官方分类页： OAP
分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA（CC0 公有领域），不构成注册策略建议。