FDA.reportPublic FDA data

510(k) K260899

Device
Laser Hair Growth Device (F21151, F21152, F21153, F21154, F21155, F21156, F21157, F21158, F21159)
Applicant
Zdeer Technology (Henan) Co., Ltd.
510(k) number
K260899
Product code
OAP
Decision
Substantially Equivalent (SESE)
Decision date
2026-06-16
Date received
2026-03-18
Regulation
890.5500
Classification name
Laser, Comb, Hair
Medical specialty
Physical Medicine
Review panel
Physical Medicine
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Wenlin Xiang
Address
East Of Wei Wu Rd. And S. Of Qin Gong E. Rd., Toubao Village Committee, Laotown Town Changge, Xuchang City CN 461500 461500

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OAP#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K261253Laser Hair Growth Devices (HR-H1, HR-H2, HR-H3, HR-H4, HR-H5, HR-H6, HR-H7, HR-H8, HR-H9, HR-H10, HR-I1, HR-I2, HR-I3, HR-I4, HR-I5)Ziree Co., Ltd.2026-06-26
K253231Laser Hair Growth System (Laser Cap 128, Laser Helmet 272, Laser Helmet 352, Laser Helmet 552, Laser Helmet 500)Hubei Yjt Technology Co.,Ltd2026-06-16
K251684Alma TED+ SystemAlma Lasers, Inc.2026-06-05
K253669TRUDERMAL HALO HAIR GROWTH SYSTEM (M-180A); ADURO HAIR GROWTH (M-130,M-300)Shenzhen Kaiyan Medical Equipment Co., Ltd.2026-01-23
K253349Hair Regrowth Cap (Model: T-119-HRC)Light Tree Ventures Europe B.V.2025-12-24
K252414Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1)Shenzhen Kaiyan Medical Equipment Co., Ltd.2025-10-30
K252325Hair Growth Laser CapCosmo Far East Technology Limited2025-10-22
K251017CurrentBody Skin Dual Light Hair Growth Helmet (model: MZ-07A)Shenzhen Kaiyan Medical Equipment Co., Ltd.2025-06-17
K250467Red Light Hair Growth Cap (LP-RJVGRW-BLK)Shenzhen Idea Light Limited2025-06-05
K250308Hair Growth Device (KCA441-200, KCA441-120, KCA441-88, KCA441-56, KCA441-200S, KCA441-120S, KCA441-88S, KCA441-56S, KCA451-200, KCA451-120, KCA451-88, KCA451-56, KCA451-200S, KCA451-120S, KCA451-88S, KCA451-56S)Dongguan Boyuan Intelligent Technology Co.,Ltd2025-04-29
K242747FAQ™ (302)Foreo, Inc.2024-12-11
K242619GroWell BT Hair Growth System (GW10042)Apira Science, Inc.2024-12-02
K242363HIGHERDOSE Red Light Hat (HG-120K)Shenzhen Kaiyan Medical Equipment Co., Ltd.2024-11-20
K241342Hair Growth Comb (SZ-23,SZ-23A)Shenzhen Nuon Medical Equipment Co., Ltd.2024-11-08
K242620Breo Laser Hair Growth Comb (Scalp 3L)Shenzhen Breo Technology Co., Ltd.2024-11-01