510(k) K252325

Device
Hair Growth Laser Cap
Applicant
Cosmo Far East Technology Limited
510(k) number
K252325
Product code
OAP
Decision
Substantially Equivalent (SESE)
Decision date
2025-10-22
Date received
2025-07-25
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

Related Records

Applicant Contact

Contact
Bob An
Address
3f Bldg. 11, Section B Of Xue Zi Wei Industrial Park Shajing St. Bo'An St. Shenzhen CN

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code OAP

510(k)DeviceApplicantDecision date
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
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
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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
K240472PBM Hair Therapy CapDongguan Tutamen Metalwork Co., Ltd.2024-10-11
K240689Robin's EggTelebrands Corporation2024-09-17
K242441Revian Lyte (10011)Revian, Inc.2024-09-13
K240456Bosley Booster 128 Laser Cap; Bosley Booster 162 Laser Cap; Bosley Booster 288 Laser CapPlm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC2024-05-22