Clearance Summary
Bosley Revitalizer 272 Laser Cap, Bosley Revitalizer 164 Laser Cup received FDA 510(k) clearance under submission number K181253, sponsored by Pjm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC. 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 2018-08-10.
- Submission: K181253
- Applicant / Sponsor: Pjm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5500
- Decision date: 2018-08-10
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.