Clearance Summary
GroWell BT Hair Growth System (GW10042) received FDA 510(k) clearance under submission number K242619, sponsored by Apira Science, Inc.. 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 2024-12-02.
- Submission: K242619
- Applicant / Sponsor: Apira Science, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5500
- Decision date: 2024-12-02
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.