Clearance Summary
SAPPHIRE, ELEVARE SAPPHIRE received FDA 510(k) clearance under submission number K172555, sponsored by Omm Imports, Inc. D/B/A Zero Gravity. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2018-05-01.
- Submission: K172555
- Applicant / Sponsor: Omm Imports, Inc. D/B/A Zero Gravity
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4810
- Decision date: 2018-05-01
Classification & Regulation
This clearance is catalogued under FDA product code OLP and 21 CFR 878.4810, within the General, Plastic Surgery review panel as a Class II device.