Clearance Summary
Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3 received FDA 510(k) clearance under submission number K161198, sponsored by Usa Laser Biotech, 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 2016-07-26.
- Submission: K161198
- Applicant / Sponsor: Usa Laser Biotech, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5500
- Decision date: 2016-07-26
Classification & Regulation
This clearance is catalogued under FDA product code ILY and 21 CFR 890.5500, within the Physical Medicine review panel as a Class II device.