Clearance Summary
SOLEOLINE, SOLEO STIM, SOLEO SONO, SOLEO SONOSTIM received FDA 510(k) clearance under submission number K121059, sponsored by Zimmer Medizinsystems GmbH. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 2012-08-07.
- Submission: K121059
- Applicant / Sponsor: Zimmer Medizinsystems GmbH
- Clearance pathway: Abbreviated
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5860
- Decision date: 2012-08-07
Classification & Regulation
This clearance is catalogued under FDA product code IMG and 21 CFR 890.5860, within the Physical Medicine review panel as a Class II device.