Clearance Summary
Laser hair growth helmet received FDA 510(k) clearance under submission number K213025, sponsored by Kam Yuen Plastic Products , 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 2022-05-12.
- Submission: K213025
- Applicant / Sponsor: Kam Yuen Plastic Products , Ltd.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5500
- Decision date: 2022-05-12
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.