Clearance Summary
Laser Hair Growth System (Laser Cap 128, Laser Helmet 272, Laser Helmet 352, Laser Helmet 552, Laser Helmet 500) received FDA 510(k) clearance under submission number K253231, sponsored by Hubei Yjt Technology Co.,Ltd. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 2026-06-16.
- Submission: K253231
- Applicant / Sponsor: Hubei Yjt Technology Co.,Ltd
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5500
- Decision date: 2026-06-16
Classification & Regulation
This clearance is catalogued under FDA product code OAP and 21 CFR 890.5500, within the Physical Medicine review panel as a Class II device.