Clearance Summary
CLEARPATH DS-120(R) LENS FLUORESCENCE BIOMICROSCOPE received FDA 510(k) clearance under submission number K112880, sponsored by Freedom Meditech, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2013-01-31.
- Submission: K112880
- Applicant / Sponsor: Freedom Meditech, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.1570
- Decision date: 2013-01-31
Classification & Regulation
This clearance is catalogued under FDA product code MYC and 21 CFR 886.1570, within the Ophthalmic review panel as a Class II device.