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OAP

Laser, Comb, Hair

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)
23 件
其中 Summary 已存档
20 份,可直接下载
FDA 历史累计 510(k)
112 件(全部年份;本站只收录近三年的明细)

FDA 分类定义

Promote hair growth in males with androgenic alopecia and norwood hamilton classification of iia to v

定义原文来自 FDA 器械分类库,属美国联邦政府作品(公有领域)。

该代码近三年的 510(k)(23 件)

数据窗口为最近三年。最新一件:2026-07-17。

510(k) 号批准日期申请人器械名称摘要
K2616752026-07-17Shenzhen Chuanghong Zhilian Technology…CHZL Red Light Therapy Hair Growth Cap (Model(s):CHZ…PDF
K2612532026-06-26Ziree Co., Ltd.Laser Hair Growth Devices (HR-H1, HR-H2, HR-H3, HR-H…PDF
K2608992026-06-16Zdeer Technology (Henan) Co., Ltd.Laser Hair Growth Device (F21151, F21152, F21153, F2…PDF
K2532312026-06-16Hubei Yjt Technology Co.,LtdLaser Hair Growth System (Laser Cap 128, Laser Helme…PDF
K2516842026-06-05Alma Lasers, Inc.Alma TED+ SystemPDF
K2536692026-01-23Shenzhen Kaiyan Medical Equipment Co.,…TRUDERMAL HALO HAIR GROWTH SYSTEM (M-180A); ADURO HA…PDF
K2533492025-12-24Light Tree Ventures Europe B.V.Hair Regrowth Cap (Model: T-119-HRC)PDF
K2524142025-10-30Shenzhen Kaiyan Medical Equipment Co.,…Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1)FDA
K2523252025-10-22Cosmo Far East Technology LimitedHair Growth Laser CapFDA
K2510172025-06-17Shenzhen Kaiyan Medical Equipment Co.,…CurrentBody Skin Dual Light Hair Growth Helmet (mode…PDF
K2504672025-06-05Shenzhen Idea Light LimitedRed Light Hair Growth Cap (LP-RJVGRW-BLK)PDF
K2503082025-04-29Dongguan Boyuan Intelligent Technology…Hair Growth Device (KCA441-200, KCA441-120, KCA441-8…PDF
K2427472024-12-11Foreo, Inc.FAQ™ (302)PDF
K2426192024-12-02Apira Science, Inc.GroWell BT Hair Growth System (GW10042)PDF
K2423632024-11-20Shenzhen Kaiyan Medical Equipment Co.,…HIGHERDOSE Red Light Hat (HG-120K)FDA
K2413422024-11-08Shenzhen Nuon Medical Equipment Co., L…Hair Growth Comb (SZ-23,SZ-23A)PDF
K2426202024-11-01Shenzhen Breo Technology Co., Ltd.Breo Laser Hair Growth Comb (Scalp 3L)PDF
K2404722024-10-11Dongguan Tutamen Metalwork Co., Ltd.PBM Hair Therapy CapPDF
K2406892024-09-17Telebrands CorporationRobin's EggPDF
K2424412024-09-13Revian, Inc.Revian Lyte (10011)PDF
K2404562024-05-22Plm Worldwide, LLC D/B/A Phoenix Medic…Bosley Booster 128 Laser Cap; Bosley Booster 162 Las…PDF
K2400642024-02-07Wontech Co., Ltd.Hair Boom Air / Ulike Hair UpUp / Hair Boom 69 / Hai…PDF
K2323562023-10-24Hubei Yjt Technology Co.,LtdLaser Cap, Model: Hat-01PDF

其中 20 件的 Summary 已存档在本站,点 PDF 直接下载;其余给 FDA 官方链接。

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。