Clearance Summary
Hair Boom 69, Hair Boom Air, Ulike Hair UpUp received FDA 510(k) clearance under submission number K192425, sponsored by Wontech Co., Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 2019-09-30.
- Submission: K192425
- Applicant / Sponsor: Wontech Co., Ltd.
- Clearance pathway: Special
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5500
- Decision date: 2019-09-30
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.