Clearance Summary
Keeogo Dermoskeleton System received FDA 510(k) clearance under submission number K201539, sponsored by B-Temia, 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 2020-09-09.
- Submission: K201539
- Applicant / Sponsor: B-Temia, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.3480
- Decision date: 2020-09-09
Classification & Regulation
This clearance is catalogued under FDA product code PHL and 21 CFR 890.3480, within the Physical Medicine review panel as a Class II device.